2015 Edwards University Course Catalog

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83

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Mission Statement

Providing employees with valued learning

opportunities that foster personal &

professional growth

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Table of Contents

COLLEGE OF ENGINEERING ............................................................................. 1

Current Good Manufacturing Practices (cGMP) and Good Documentation Practices

(GDP) ........................................................................................................................................... 2

Design Control ........................................................................................................................... 2

Design of Experiment (DOE) ..................................................................................................... 3

Equipment Calibration and Metrology ..................................................................................... 3

Installation Qualification/Operational Qualification (IQ/OQ) ................................................. 4

Performance & Process Performance Qualification (PQ & PPQ) ......................................... 4

Risk Management ...................................................................................................................... 5

Root Cause Analysis ................................................................................................................. 5

Sampling Plans .......................................................................................................................... 6

Test Method Validation (TMV)................................................................................................... 6

Geometric Dimensioning and Tolerance (GD&T) Fundamentals.......................................... 7

Geometric Dimensioning Applications and Tolerance Stacks ............................................. 8

Good Technical Writing ............................................................................................................. 8

Intro to Minitab and Basic Statistics ........................................................................................ 9

Level 1 Training – Introduction to Creo Parametric 2.0 ......................................................... 9

Level 2 Training – Advanced Assembly, Modeling and Detailing for Creo Parametric 2.0

................................................................................................................................................... 10

Minitab Non-Normal Data Analysis ........................................................................................ 10

Mistake Proofing ...................................................................................................................... 11

PathWise Investigations and CAPA ....................................................................................... 11

PathWise Technical Writing .................................................................................................... 12

Process Validation ................................................................................................................... 13

Reading and Interpreting Drawings ....................................................................................... 13

Risk Management/FMEA ......................................................................................................... 14

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Root Cause Analysis ............................................................................................................... 14

Statistical Process Control (SPC) .......................................................................................... 15

Train the Trainer ....................................................................................................................... 15

COLLEGE OF QUALITY, REGULATORY AND CLINICAL ................................ 16

Current Good Manufacturing Practices (cGMP) and Good Documentation Practices

(GDP) ......................................................................................................................................... 17

Design Control ......................................................................................................................... 17

Design of Experiment (DOE) ................................................................................................... 18

Equipment Calibration and Metrology ................................................................................... 18

Installation Qualification/Operational Qualification (IQ/OQ) ............................................... 19

Process & Process Performance Qualification (PQ & PPQ) ............................................... 19


Risk Management .................................................................................................................... 20


Sampling Plans ........................................................................................................................ 21

Test Method Validation (TMV)................................................................................................. 22

Geometric Dimensioning and Tolerance (GD&T) Fundamentals........................................ 23

Geometric Dimensioning Applications and Tolerance Stacks ........................................... 24

Good Technical Writing ........................................................................................................... 24

Intro to Minitab and Basic Statistics ...................................................................................... 25

Lead Auditor of the Quality Management System ISO-13485:2003 Requirements ........... 25

Level 1 Training – Introduction to Creo Parametric 2.0 ....................................................... 26

Level 2 Training – Advanced Assembly, Modeling and Detailing for Creo Parametric 2.0

................................................................................................................................................... 27

Minitab Non-Normal Data Analysis ........................................................................................ 28

Mistake Proofing ...................................................................................................................... 28

PathWise Investigations and CAPA ....................................................................................... 29

PathWise Technical Writing .................................................................................................... 30

3

Process Validation ................................................................................................................... 31


Risk Management/FMEA ......................................................................................................... 32


Statistical Process Control (SPC) .......................................................................................... 33

Train the Trainer ....................................................................................................................... 33

Global Regulatory Strategy for Medical Devices .................................................................. 34

Good Clinical Practices (GCPs) ............................................................................................. 35

Good Laboratory Practices (GLPs) ........................................................................................ 35

Good Manufacturing Practices (GMPs) ................................................................................. 36

Medical Devices: Canadian Regulations ............................................................................... 36

Medical Devices: China, Japan, Singapore and South Korea Regulation Overview ........ 37

Medical Devices: Compliance and Audits ............................................................................. 37

Medical Devices: Corrections, Removals and Directed Recalls ......................................... 38

Medical Devices: Definition and Lifecycle ............................................................................ 39

Medical Devices: EU Regulations .......................................................................................... 39

Medical Devices: Postmarket Surveillance ........................................................................... 40

Medical Devices: Risk Management ...................................................................................... 41

Medical Devices: US Regulations .......................................................................................... 41

Regulation of Combination Products .................................................................................... 42

Quality System Regulation (QSR) .......................................................................................... 43

Regulation of IVDs in the US .................................................................................................. 43

Understanding and Managing US Clinical Trial Process ..................................................... 44

SUPPLY CHAIN.................................................................................................. 45

S&OP Process/Tools for Experienced Users (JDA/QlikView) ............................................. 46

COLLEGE OF SALES & MARKETING ............................................................... 47

Healthcare Economics & Policy Program ............................................................................. 48

Hospital Financial Acumen ..................................................................................................... 48

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Leading Amidst Change .......................................................................................................... 49

Negotiation Skills- Introduction Workshop ........................................................................... 49

Advanced Negotiation Skills Workshop ................................................................................ 50

CARDIAC SURGERY SYSTEMS ....................................................................... 51

CSS Advanced Course ............................................................................................................ 52

CSS Fundamentals Course ..................................................................................................... 52

CRITICAL CARE ................................................................................................. 53

Anatomy and Physiology ........................................................................................................ 54

ClearSight Limited Launch Training Course ......................................................................... 54

Edwards Vigilance II ................................................................................................................ 55

EV1000 Simulator Training ..................................................................................................... 55

The EV1000 Clinical Platform ................................................................................................. 56

The FloTrac System ................................................................................................................. 56

The Intravascular Monitoring and Set Up with TruWave Transducer ................................ 57

The Oxygen Delivery (DO2) and Oxygen Consumption (VO2) Concepts ............................ 57

The Stroke Volume Variation (SVV) ....................................................................................... 58

The TruWave Transducer ........................................................................................................ 58

The VAMP Adult System ......................................................................................................... 59

The VAMP Flex System ........................................................................................................... 59

The VAMP Junior System ....................................................................................................... 60

The VAMP Plus System ........................................................................................................... 60

The Venous Oximetry .............................................................................................................. 61

The Vigileo Monitor .................................................................................................................. 61

The VolumeView System ......................................................................................................... 62

HEART VALVE THERAPY ................................................................................. 63

Employee Case Observations ................................................................................................ 64

HVT Basic Training .................................................................................................................. 64

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TRANSCATHETER HEART VALVE ................................................................... 65

ACC2011: Clinical Trial Design and the Edwards Transcatheter Heart Valve Clinical

Program .................................................................................................................................... 66

ACC2011: The PARTNER Trial: Overview and Design - Cohort B Results ....................... 66

CT for TAVR Video ................................................................................................................... 66

Echo for TAVR Video ............................................................................................................... 66

Patient Video, Logistics- Own the Moment Video ................................................................ 67

Retroflex 3 Patient Screening e-Learning ............................................................................. 67

Structural Heart Anatomy Course .......................................................................................... 67

LEADERSHIP DEVELOPMENT CENTER OF EXCELLENCE ........................... 68

Critical Thinking ....................................................................................................................... 69

Crucial Conversations ............................................................................................................. 69

Finance for Non-Financial Managers ..................................................................................... 70

Leading Across Generation .................................................................................................... 70

Leading at Edwards: Your Role and Your Team................................................................... 71

Leading at Edwards: Performance Management and Engagement ................................... 71

Leading at Edwards: Learning From Our Leaders ............................................................... 72

Leading Strategic Execution................................................................................................... 72

Leveraging Diversity ................................................................................................................ 73

Presentation Skills – Power Speaking® ................................................................................ 73

Project Management Essentials for the Unofficial Project Manager .................................. 74

Situation Leadership II ............................................................................................................ 75

The 5 Choices to Extraordinary Productivity Essentials ..................................................... 76

The 7 Habits of Highly Effective People ................................................................................ 77

Working Across Generations ................................................................................................. 77

Best Management Practices ................................................................................................... 78

ELLP I: Edwards Lifesciences Leadership Program I .......................................................... 79

ELLP II: High Performance Leadership ................................................................................. 79

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Leaders Forum ......................................................................................................................... 80

CORPORATE BUSINESS PRACTICES CENTER OF EXCELLENCE .............. 81

Advertising and Promotion Boot Camp ................................................................................ 82

Contracts Boot Camp .............................................................................................................. 82

Edwards’ Corporate Culture ................................................................................................... 83

Edwards’ Global Business Practice Standards (“Titanium Book”) .................................... 83

Intellectual Property Boot Camp ............................................................................................ 84

Sunshine Law Awareness – Module I Transparency Requirements .................................. 84

BUSINESS EXCELLENCE (BEST) CENTER OF EXCELLENCE ...................... 85

Black Belt .................................................................................................................................. 86

Champion Training .................................................................................................................. 86

Control Charting ...................................................................................................................... 87

Design of Experiments (DOE) ................................................................................................. 87

Gage R&R ................................................................................................................................. 88

Green Belt ................................................................................................................................. 88

NPD Excellence Champion Training ...................................................................................... 89

NPD Excellence Design for Manufacturability (DFM) Workshops ...................................... 89

NPD Excellence Market Requirements & Risk Mitigation .................................................... 90

NPD Excellence Project Planning & Visual Workflow Management Workshop ................ 90

5S for the Factory/Workplace ................................................................................................. 91

Batch vs. Flow Simulation ...................................................................................................... 91

BEST Lean System (BLS) ........................................................................................................ 92

BEST pFMEA Mistake Proofing Process ............................................................................... 92

Change Management ............................................................................................................... 93

Kaizen ........................................................................................................................................ 93

Kanban ...................................................................................................................................... 94

Lean Management System ...................................................................................................... 94

Lean Overview for Operators/Professionals ......................................................................... 95

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PFEP (Plan for Every Part) ...................................................................................................... 95

Process Flow Analysis ............................................................................................................ 95

Project Charter Training .......................................................................................................... 96

Transactional Process Mapping ............................................................................................. 96

Value Stream Mapping ............................................................................................................ 96

EMPLOYEE ON-BOARDING ............................................................................. 97

Anatomy and Physiology ........................................................................................................ 98

New Employee Orientation ..................................................................................................... 98

Preventing Workplace Harassment ....................................................................................... 99

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College of Engineering

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CORE ENGINEERING CURRICULUM

This instructor-led Certificate Program has been designed to support a fast-track process of

learning to develop the basic core technical skills common to R&D, Manufacturing and Quality

Engineers across our company. It also provides the opportunity to on-board new technical talent,

as well as to promote technical, business acumen, and compliance proficiency.

Participation requires mandatory attendance at all 10 sessions listed below, a $1500 investment,

and your support to sustain this commitment. Each session (held in Irvine) will last 3-4 hours and

will occur every 2 weeks over 5 months.

Current Good Manufacturing Practices (cGMP) and Good Documentation

Practices (GDP)

Course ID: TECH10033

An overview of Edward’s Quality Policy that assures proper design, monitoring, and control of

manufacturing processes, facilities, and quality records. This course also describes the minimum

requirements for good documentation practices for quality records

Upon completion of this course, you will be able to:

Determine why certain major food, drug and device laws and regulations came into effect

Identify the quality requirements listed in the FDA’s Quality System Regulations for medical device manufacturers

Summarize what the requirements mean in simple language

Identify how Edwards complies with these regulations

Understand how good documentation practices contribute to the Quality System

Target Audience: R&D, Engineering, RA, QA, Manufacturing, Advanced Technology,

Packaging

Location: Irvine Duration: 4 hrs Investment: $0

Design Control


This training offers an overview of the different product development phases from a project

management and design control perspective. This course highlights the regulatory compliance

documents, funding gates, plans, and design reviews required at each phase.


Name the components of Design Control (DC)

List the 4 phases of the product development process

Identify the Design Control milestones that are associated with each phase


Packaging

Location: Irvine Duration: 3-4 hrs Investment: $0

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Design of Experiment (DOE)


This training module introduces a systematic approach to experiment modeling and an effective

way to optimize process parameters and specifications.


Define a Design of Experiment (DOE)

Identify key DOE factors, inputs and outputs

Recognize the benefits of doing an DOE

List the steps required for conducting a DOE

Identify basic experimental designs and examples


Packaging


Equipment Calibration and Metrology


This course will cover calibration and metrology preventative maintenance requirements.


Describe the calibration process

Define calibration terminology

Interpret calibration reports

List calibration and PM requirements


Packaging


4

Installation Qualification/Operational Qualification (IQ/OQ)


The IQ/OQ provides objective evidence the equipment is installed per Edwards Lifesciences and

equipment manufacturer’s requirements. IQ/OQ also defines the equipment operational ranges

and if its performance is both stable and predictable.

Upon completion of this course, you’ll be able to:

Consider validation requirements when purchasing and preparing to install a particular piece of equipment

Identify key process and/or equipment parameters and verify the equipment functions correctly

Provide assurance that the equipment is stable across anticipated operating ranges and tolerances

Target Audience: R &D, Engineering, RA, QA, Manufacturing, Advanced Technology,

Packaging


Performance & Process Performance Qualification (PQ & PPQ)


This training module covers two phases of Process Validation: Performance Qualification and

Product Performance Qualification. This module includes the methodology and compliance

requirements to validate individual processes (PQ), and a system of processes (PPQ), prior to

commercial product launch.


Define PQ and PPQ

Distinguish the differences between validation, verification and qualification

Recognize how to prepare and execute a PQ

Recognize how to prepare and execute a PPQ

Identify PPQ triggers, pre-requisites, types and requirements


Packaging


5

Risk Management


Introduces the elements of risk management: identification, assessment, and prioritization of

risks. It includes discussion of appropriate resources to minimize, monitor, and control the

probability and/or impact of unfortunate events or to maximize the realization of opportunities.


Define and explain the purpose of risk management

List the phases of the risk management cycle

Identify the three types of risk analysis

Recognize how Edwards does risk management


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Root Cause Analysis


Introduces a methodological approach to root cause investigation and problem solving techniques

to improve design development and process transfers to a production environment.


Define Root Cause Analysis (RCA)

Identify the 5 stages involved in doing an RCA

Determine which tool is appropriate for each stage of the RCA


Packaging


6

Sampling Plans


Provides guidance to determining the number of samples required for design verification, design

validation, and quality control plans. This course links Edwards’ statistical approach to risk

management and mitigation.


Define and explain the value of sampling

List the steps involved in sampling

Identify the two types of sampling data

List the sampling approaches and sampling risks

Explain how the Acceptable Quality Level (AQL), Lot Tolerance Percent Defective (LTPD), power analysis, and confidence intervals are factored into acceptance sampling

Identify the key components of OC curves

Review the varies industry and Edwards standards available for sampling


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Test Method Validation (TMV)


Lays out the elements of test method development, as well as the validation requirements

applicable.


Identify the elements in a Test Method

Identify the pre-requisites that must be in place for each element before TMV can be performed

Distinguish the difference between validation and verification

Recognize how Edwards does Test Method Validation

Name the TMV categories, types, and attributes


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ADVANCED TECHINCAL CURRICULUM

The Advanced Technical Curriculum consists of instructor-led, online e-learning, and mentoring that provides employees with access to a variety of performance tools and technical training workshops with practical hands-on learning. This curriculum compliments the Core Technical Training Program by taking a more in-depth view of the subjects with Edwards’ specific projects.

These courses are specific to Quality and Engineering; the courses range from 1- 5 days in duration with pre and post training effectiveness.

Post training guidance and performance support is provided in the form of internal subject matter experts and Trainers from Edwards University.

Training coordination and administration includes registration, tracking student progress on training modules, and overall utilization of the Advanced Technical Training Programs.

Version controlled content

Faculty that has successfully completed a Train-the-Trainer session for each program may facilitate and instruct.

Geometric Dimensioning and Tolerance (GD&T) Fundamentals


This Geometric Dimensioning and Tolerance (GD&T) Fundamentals program presents geometric

tolerancing based on the latest “state of the art” ASME Y14.5-2009 standard. This standard is

greatly enhanced from earlier versions. New symbols and concepts have been added and the

definitions have been tweaked.

This course is designed to explain the geometric concepts and make them more user friendly and

easy to interpret and apply. The training presentation contains hundreds of color computer

animated graphics, video clips and plastic models which allow the students to clearly understand

the concepts. There is extensive discussion on the establishment of the datum reference frame

and the application of the MMC, LMC and RFS feature modifiers as well as the MMB, LMB and

RMB datum feature modifiers. The application, measurement and data reporting for position and

profile tolerances are also covered in detail. The training program is customized to meet the class

needs.

The training is exceptionally student interactive. Wireless transponders are provided to each

student where they can provide instant real time feedback on screen to the instructor and other

students as they progress through the learning process. The transponders and instant feedback

feature makes the class fun, interesting, interactive and easy to learn.

Participants are encouraged to bring parts and prints to class for discussion.

Upon completing this program, the students will have:

A solid foundation in the fundamentals of geometric tolerancing

Knowledge on all the rules, measurement theory, datum reference frames, form, orientation, profile, positional tolerancing and the feature and datum feature modifier concepts

Target Audience: Engineers, Designers, Drafters, Quality, Procurement, Tooling, Production,

Purchasing Manufacturing, CAD, Inspection and Shop personnel

Location: Irvine Duration: 3 days Investment: $600

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Geometric Dimensioning Applications and Tolerance Stacks


This course is an advanced level design course for engineers, designers, drafters,

quality, tooling, and manufacturing personnel. As a prerequisite, it is highly recommended the

students attend the Geometric Tolerance Fundamentals class. There will be minimal review of the

geometric tolerance fundamentals.

Course Highlights: Using computer animated color graphics and demonstrations using wood and

plastic models, student teams will learn to apply and verify geometric tolerance. The participants

will apply geometric tolerance to a series of case study problems to meet functional requirements.

The problems include a variety of molded, sheet metal, machined parts, wire formed and welded

assemblies.

Target Audience: R&D, Engineering, RA, QA, Manufacturing, Advanced Technology, Drafters,

Packaging

Location: Irvine Duration: 2 1/2 days Investment: $800

Good Technical Writing


This course teaches proven writing skills needed for compliant, effective, and efficient technical

documentation. Employees learn clear, concise, and cohesive writing techniques. In-class

workbook exercises, discussions, and real life examples provide channels of instant application of

these technical writing skills.


Explain why good technical writing is important.

Identify the elements of style, general grammar guidelines, and the appropriate content for your communication

Identify the guidelines to good compliance writing

Identify the appropriate content for your communication.


Packaging


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Intro to Minitab and Basic Statistics


This course will help augment your graphical analysis skills using Minitab’s powerful statistical

tools. A strong emphasis is placed on making good business decisions based upon the practical

application of statistical techniques commonly found in manufacturing, engineering, research and

development endeavors.


Develop the foundation for important statistical concepts such as hypothesis testing and confidence intervals.

By analyzing a variety of real world data sets, learn how to match the appropriate statistical tool to your own applications

Learn how to correctly interpret statistical output to quickly reveal problems with a process or to show evidence of an improvement.

Learn how to explore critical features in your processes through statistical modeling tools that help to uncover and describe relationships between variables.


Packaging


Level 1 Training – Introduction to Creo Parametric 2.0


In this course, you will learn core modeling skills and quickly become proficient with Creo

Parametric 2.0. Topics include sketching, part modeling, assemblies, drawings, and basic model

management techniques. The course also includes a comprehensive design project that enables

you to practice your new skills by creating realistic parts, assemblies, and drawings. After

completing the course, you will be well prepared to work effectively on product design projects

using Creo Parametric 2.0.


Learn how to use the Creo Parametric interface

Select and edit geometry, features, and models

Sketch geometry and using tools

Create sketches for features

Utilize internal sketches and embedded datum

Create holes, shells, and drafts, rounds and chamfers

Assemble with constraints

Lay out drawings and creating views

Create drawing annotations

Capture and manage design intent

Target Audience: Product Designers, Drafters, Industrial/Conceptual Designers, and Routed

Systems Designers

Location: Irvine Duration: 5 days Investment: $1,650

10

Level 2 Training – Advanced Assembly, Modeling and Detailing for Creo

Parametric 2.0


In this course you will learn how to use Creo Parametric 2.0 to create and manage complex

assemblies, use advanced part modeling techniques to improve your product design and create

detailed drawings using information captured within 3-D design models.


Replace components in an assembly Understand the basics of simplified reps Create cross-sections, display styles, layer states and combined views Create and use assembly structure and skeletons Learn advanced selection techniques Create advanced drafts and ribs Create advanced rounds and chamfers Create sweeps with variable sections Learn advanced layer techniques Add draft geometry and symbols to drawings Use layers in drawings to control the display of views and detail items Creating and using tables in drawings

Target Audience: Mechanical Designers, Design Engineers and related roles

Pre-requisite: Introduction to Creo Parametric 2.0 Update to Creo Parametric 2.0 from Creo

Elements/Pro.


Minitab Non-Normal Data Analysis


Topics include: 1-, 2-, and multi-sample Non-Parametric Confidence Intervals and Hypothesis

Tests, Parametric and Nonparametric Distribution Analysis, Estimation and Demonstration Test

Plans, Acceptance Sampling Plans for Continuous and Attribute Data


Use Non-parametric confidence intervals and hypothesis tests appropriate for non-normal data comparisons.

Explore the common distributions used to model non-normal data—often associated with failure modes–and develop necessary skills in choosing these distributions.

Determine non-normal distribution characteristics of a product using both graphical and quantitative analysis methods.

Determine sample sizes for estimating percentiles, and non-normal hypothesis tests.

Compare and select Acceptance Sampling Plans to ensure appropriate lot inspection and rejection criteria.

Target Audience: R&D, Engineering, RA, QA, Manufacturing, Advanced Technology

Packaging

Location: Irvine Duration: 1-2 Days Investment: $400

11

Mistake Proofing


The best way to prevent defects is to examine the process, determine the conditions leading to

those defects, and control those conditions. Mistake proofing devices and techniques can prevent

or minimize errors or defective operating conditions. This course teaches engineers, managers,

technicians and operators how to develop and implement mistake proofing techniques that can

be used to avoid or control defects in daily operations.


Define mistake proofing

Articulate the importance of mistake proofing in manufacturing

Recall types of human error and system error

Distinguish the difference between procedural controls and engineering controls

List types and examples of mistake proofing devices

Identify when mistake proofing should be applied

List the steps for mistake proofing

Apply mistake proofing principals to a given scenario


Packaging

Location: Irvine Duration: 1 Day Investment: $400

PathWise Investigations and CAPA


The PathWise Investigations & CAPA training course is designed to meet the requirements

mandated by world regulatory bodies to effectively investigate and locate causes and correct

them. The attendees will learn how to properly identify non-conformances (problems), how to

assess and prioritize them based on risk, and how to implement a proper corrective and/or

preventive action.

Upon completion of this course, you will learn how to:

Minimize repeat investigations.

Reduce length and number of investigations.

Identify true root causes.

Pinpoint root causes using facts instead of guesswork or opinion.

Avoid costly experiments and trial fixes by logically testing possible causes.

Assess and prioritize each Event based on risk.

Target potential problems before they happen and develop actions to prevent them.

Check effectiveness of corrective actions in the CAPA system.


Packaging

Location: Irvine/Draper Duration: 2 Days Investment: $800

12

PathWise Technical Writing


Day 1 Required for all to attend: Through the knowledge gained in this course, the attendees will gain insight into the following:

Understand what the FDA and world regulatory bodies expect

How to write for multiple audiences who will be reading the document

Document design and control and the quality of technical writing

Documentation alignment

Explain regulatory requirements with respect to your organization

Write clear, concise, and cohesive documents


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Day 2-3 you can choose from:

Writing Validation Documents

Through the knowledge gained in this course, the attendees will gain insight into the following:

Considerations of Writing Validation Documents

Qualities of a Sound Document

Regulatory Requirements

Validation Document Planning

What makes a good Validation Master Plan, Protocol, Report

And/Or

Writing Standard Operating Procedures (SOPs)


Considerations when writing SOPs



Clear and Concise Steps

Planning your document

And/Or

Documenting Investigations


Considerations when Writing Investigation Reports



Getting to a Sound Problem Statement

Creating specific Root Cause and CAPA Statements

Creating Stand-Alone Documents


Packaging

Location: Irvine Duration: 1- 3 Days Investment: $600/day

13

Process Validation


The purpose of this course is to provide an in-depth training on process validation, explaining

how, when, where and why one should validate. Students learn the value of executing a

validation strategy early in the product development process and how this results in robust

processes and delivery of consistent product to the customer. Students receive an overview of

the template-based validation process which facilitates protocol and report writing to ensure

consistency throughout the organization.

By the end of this course, participants will learn how an effective process validation system is a

critical requirement to the movement toward a risk-based approach to compliance and product

safety.


Describe the purpose of process validation

Identify the general process validation workflow

Reference the associated regulations and global standard operating procedures for process validation

Determine and complete the requirements for equipment qualification and process validation


Packaging

Location: Irvine Duration: 3 Days Investment: $600

Reading and Interpreting Drawings


When engineers design, there must be a standard way to convey them so that someone producing the designs will understand with 100% confidence what was drawn. Thinking in the language of engineering graphics, you will visualize problems more clearly and will use graphic images to find solutions with greater ease.


Identify the elements of a drawing sheet & text drawings (off-the-shelf)

Identify line styles that are used in drawings

Draw and interpret orthographic projections

Determine measurements for objects drawn on orthographic projections and associated views (sectional, auxiliary, and detail)

Identify general notes guidelines

Properly document threads

Understand dimensioning and design intent

Read assembly prints (product and tooling)


Packaging

Location: Irvine Duration: Half Day Investment: $200

14

Risk Management/FMEA


Can you demonstrate your understanding of the Edwards Risk Management program when your

next inspection occurs? Without comprehensive understanding, you are open to FDA inspection

and submission problems as well as possible enforcement action.

This course introduces the elements of the Risk Management program: identification,

assessment, and prioritization of risks. It includes discussion of appropriate resources to

minimize, monitor, and control the probability and/or impact of unfortunate events or to maximize

the realization of opportunities.







Packaging


Root Cause Analysis


Root cause analysis is a general approach to problem investigation regardless of product

category or problem type. This investigation method is used to address a problem or non-

conformance, in order to get to the root cause of the problem. It is used to correct or eliminate the

cause and prevent the problem from recurring.


Apply practical theory of root cause analysis as a problem solving technique to improve a process

Identify the five stages of the root cause analysis procedure and understand how these stages serve as a methodical approach to problem solving

Demonstrate the application of key tools available for problem solving

Differentiate among the root cause analysis tools based on which tool is appropriate for each stage

Demonstrate proficiency in using SOP6221 to perform a root cause analysis through a scenario-based exercise


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15

Statistical Process Control (SPC)


This module offers an overview of SPC, including a short history, types of data and the variety of

charts available for performing Statistical Process Control.


Identify types of data used in SPCs

Distinguish between special cause and common cause variation

Map out and interpret SPC chart data

Determine the appropriate type of SPC chart to use based on given scenarios


Packaging


Train the Trainer


Driving Effective Learning: provides an overview and practical application on how to develop

and deliver impactful training that is interactive and engaging. Topics covered include: adult

learning principles, phases of learning, instructor’s roles and responsibilities, managing difficult

participants, and designing effective training content.


Identify the techniques for opening and closing the class

Define basic adult learning styles

Identify the 4 phases of learning

Define the instructor’s role as a facilitator and trainer

Successfully apply presentation techniques

Manage discussions in a productive and balanced way

Identify common participant types

Effectively handle difficult participants

Use the ADDIE Model (Analysis, Design, Development, Implementation, and Evaluation) to design training content

Target Audience: Anyone who may be designing, developing or delivering training

Location: Irvine Duration: 1 to 2 Days Investment: $300

16

College of Quality, Regulatory

and Clinical

17

CORE ENGINEERING CURRICULUM

This instructor-led Certificate Program has been designed to support a fast-track process of

learning to develop the basic core technical skills common to R&D, Manufacturing and Quality

Engineers across our company. It also provides the opportunity to on-board new technical talent,

as well as to promote technical, business acumen, and compliance proficiency.

Participation requires mandatory attendance at all 10 sessions listed below, a $1500 investment,

and your support to sustain this commitment. Each session (held in Irvine) will last 3-4 hours and

will occur every 2 weeks over 5 months.

Current Good Manufacturing Practices (cGMP) and Good Documentation

Practices (GDP)


An overview of Edward’s Quality Policy that assures proper design, monitoring, and control of

manufacturing processes, facilities, and quality records. This course also describes the minimum

requirements for good documentation practices for quality records


Determine why certain major food, drug and device laws and regulations came into effect

Identify the quality requirements listed in the FDA’s Quality System Regulations for medical device manufacturers

Summarize what the requirements mean in simple language

Identify how Edwards complies with these regulations

Understand how good documentation practices contribute to the Quality System


Packaging


Design Control


Offers an overview of the different product development phases from a project management and

design control perspective. This course highlights the regulatory compliance documents, funding

gates, plans, and design reviews required at each phase.


Name the components of Design Control (DC)

List the 4 phases of the product development process

Identify the Design Control milestones that are associated with each phase


Packaging


18

Design of Experiment (DOE)


Introduces a systematic approach to experiment modeling, and an effective way to optimize

process parameters and specifications.


Define a Design of Experiment (DOE)

Identify key DOE factors, inputs and outputs

Recognize the benefits of doing an DOE

List the steps required for conducting a DOE

Identify basic experimental designs and examples


Packaging


Equipment Calibration and Metrology


This course will cover calibration and metrology preventative maintenance requirements.


Describe the calibration process

Define calibration terminology

Interpret calibration reports

List calibration and PM requirements


Packaging


19

Installation Qualification/Operational Qualification (IQ/OQ)


IQ/OQ confirms that equipment is installed per manufacturer’s recommendation/specifications

and Edwards’ requirements. IQ/OQ also defines the equipment operational ranges, and if its

performance is both stable and predictable.


Consider validation requirements when purchasing and preparing to install a particular piece of equipment

Identify key process and/or equipment parameters and verify the equipment functions correctly

Provide assurance that the equipment is stable across anticipated operating ranges and tolerances


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Process & Process Performance Qualification (PQ & PPQ)


Lays out the methodology and compliance requirements to validate individual processes (PQ),

and a system of processes (PPQ), prior to commercial product launch.


Define PQ and PPQ

Distinguish the differences between validation, verification and qualification

Recognize how to prepare and execute a PQ

Recognize how to prepare and execute a PPQ

Identify PPQ triggers, pre-requisites, types and requirements


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An introduction to understanding the creation, revision, interpretation, and elements of technical

drawings.


Identify the elements of a drawing sheet and the line styles used in drawings


Visualize sectional, auxiliary, and detail views




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Risk Management


Introduces the elements of risk management: identification, assessment, and prioritization of

risks. It includes discussion of appropriate resources to minimize, monitor, and control the

probability and/or impact of unfortunate events or to maximize the realization of opportunities.







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Root Cause Analysis


Introduces a methodological approach to root cause investigation and problem solving techniques

to improve design development and process transfers to a production environment.


Define Root Cause Analysis (RCA)

Identify the 5 stages involved in doing an RCA

Determine which tool is appropriate for each stage of the RCA


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Sampling Plans


Provides guidance to determining the number of samples required for design verification, design

validation, and quality control plans. This course links Edwards’ statistical approach to risk

management and mitigation.


Define and explain the value of sampling

List the steps involved in sampling

Identify the two types of sampling data

List the sampling approaches and sampling risks

Explain how the Acceptable Quality Level (AQL), Lot Tolerance Percent Defective (LTPD), power analysis, and confidence intervals are factored into acceptance sampling

Identify the key components of OC curves

Review the varies industry and Edwards standards available for sampling


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Test Method Validation (TMV)


Lays out the elements of test method development, as well as the validation requirements

applicable.


Identify the elements in a Test Method

Identify the pre-requisites that must be in place for each element before TMV can be performed

Distinguish the difference between validation and verification

Recognize how Edwards does Test Method Validation

Name the TMV categories, types, and attributes


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ADVANCED TECHINCAL CURRICULUM

The Advanced Technical Curriculum consists of instructor-led, online e-learning, and mentoring that provides employees with access to a variety of performance tools and technical training workshops with practical hands-on learning. This curriculum compliments the Core Technical Training Program by taking a more in-depth view of the subjects with Edwards’ specific projects.

These courses are specific to Quality and Engineering and range from 1- 5 days in duration with pre and post training effectiveness.

Post training guidance and performance support is provided in the form of internal subject matter experts and Trainers from Edwards University.

Training coordination and administration includes registration, tracking student progress on training modules, and overall utilization of the Advanced Technical Training Programs.

Version controlled content

Faculty who has successfully completed a Train-the-Trainer session for each program may facilitate and instruct.

Geometric Dimensioning and Tolerance (GD&T) Fundamentals


This Geometric Dimensioning and Tolerance (GD&T) Fundamentals program presents geometric

tolerancing based on the latest “state of the art” ASME Y14.5-2009 standard. This standard is

greatly enhanced from earlier versions. New symbols and concepts have been added and the

definitions have been tweaked.

This course is designed to explain the geometric concepts and make them more user friendly and

easy to interpret and apply. The training presentation contains hundreds of color computer

animated graphics, video clips and plastic models which allow the students to clearly understand

the concepts. There is extensive discussion on the establishment of the datum reference frame

and the application of the MMC, LMC and RFS feature modifiers as well as the MMB, LMB and

RMB datum feature modifiers. The application, measurement and data reporting for position and

profile tolerances are also covered in detail. The training program is customized to meet the class

needs.

The training is exceptionally student interactive. Wireless transponders are provided to each

student where they can provide instant real time feedback on screen to the instructor and other

students as they progress through the learning process. The transponders and instant feedback

feature makes the class fun, interesting, interactive and easy to learn.

Participants are encouraged to bring parts and prints to class for discussion.

Upon completing this program, the students will have:

A solid foundation in the fundamentals of geometric tolerancing

Knowledge on all the rules, measurement theory, datum reference frames, form, orientation, profile, positional tolerancing and the feature and datum feature modifier concepts

Target Audience: Designed for anyone who needs to read an engineering drawing including:

Engineers, Designers, Drafters, Quality, Procurement, Tooling, Production, Purchasing Manufacturing, CAD, Inspection and Shop personnel


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Geometric Dimensioning Applications and Tolerance Stacks


This course is an advanced level design course for engineers, designers, drafters,

quality, tooling, and manufacturing personnel. As a prerequisite, it is highly recommended the

students attend the Geometric Tolerance Fundamentals class. There will be minimal review of the

geometric tolerance fundamentals.

Course Highlights: Using computer animated color graphics and demonstrations using wood and

plastic models, student teams will learn to apply and verify geometric tolerance. The participants

will apply geometric tolerance to a series of case study problems to meet functional requirements.

The problems include a variety of molded, sheet metal, machined parts, wire formed and welded

assemblies.

Target Audience: R&D, Engineering, RA, QA, Manufacturing, Advanced Technology, Drafters,

Packaging

Location: Irvine Duration: 2 1/2 days Investment: $800

Good Technical Writing


This course teaches proven writing skills needed for compliant, effective, and efficient technical

documentation. Employees learn clear, concise, and cohesive writing techniques. In-class

workbook exercises, discussions, and real life examples provide channels of instant application of

these technical writing skills.


Explain why good technical writing is important.

Identify the elements of style, general grammar guidelines, and the appropriate content for your communication

Identify the guidelines to good compliance writing

Identify the appropriate content for your communication.


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Intro to Minitab and Basic Statistics


This course will help augment your graphical analysis skills using Minitab’s powerful statistical

tools. A strong emphasis is placed on making good business decisions based upon the practical

application of statistical techniques commonly found in manufacturing, engineering, research and

development endeavors.


Develop the foundation for important statistical concepts such as hypothesis testing and confidence intervals.

By analyzing a variety of real world data sets, learn how to match the appropriate statistical tool to your own applications

Learn how to correctly interpret statistical output to quickly reveal problems with a process or to show evidence of an improvement.

Learn how to explore critical features in your processes through statistical modeling tools that help to uncover and describe relationships between variables.


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Lead Auditor of the Quality Management System ISO-13485:2003

Requirements


This training is conducted for qualified Quality Professionals who are identified as lead auditors of

the Quality Management System ISO-13485:2003 Requirements. This training is conducted by a

registered QMS Quality Management System independent lead assessor, certified instructor and

consultant.


Understand the Quality Systems standards and requirements set forth in ISO-13485

Identify the Lead Auditor qualification requirements, and the objectives of an audit


Know the stages of an Internal Quality Audit

Identify objective evidence and reporting of findings, and more

An exam is given on the last day where a score of 70% or better is required to be certified as a

Lead Auditor.

Target Audience: Quality Systems Professionals


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Level 1 Training – Introduction to Creo Parametric 2.0


In this course, you will learn core modeling skills and quickly become proficient with Creo

Parametric 2.0. Topics include sketching, part modeling, assemblies, drawings, and basic model

management techniques. The course also includes a comprehensive design project that enables

you to practice your new skills by creating realistic parts, assemblies, and drawings. After

completing the course, you will be well prepared to work effectively on product design projects

using Creo Parametric 2.0.


Learn how to use the Creo Parametric interface

Select and edit geometry, features, and models

Sketch geometry and using tools

Create sketches for features

Utilize internal sketches and embedded datum

Create holes, shells, and drafts, rounds and chamfers

Assemble with constraints

Lay out drawings and creating views

Create drawing annotations

Capture and manage design intent

Target Audience: Product Designers, Drafters, Industrial/Conceptual Designers, and

Routed Systems Designers

People in related roles will also benefit from taking this course. This is a condensed version

of the Introduction course; users should have an understanding of basic modeling skills in the

CAD environment

Location: Irvine Duration: 5 Days Investment: $1,650

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Level 2 Training – Advanced Assembly, Modeling and Detailing for Creo

Parametric 2.0


In this course you will learn how to use Creo Parametric 2.0 to create and manage complex

assemblies, use advanced part modeling techniques to improve your product design and create

detailed drawings using information captured within 3-D design models.


Replace components in an assembly Understand the basics of simplified reps Create cross-sections, display styles, layer states and combined views Create and use assembly structure and skeletons Learn advanced selection techniques Create advanced drafts and ribs Create advanced rounds and chamfers Create sweeps with variable sections Learn advanced layer techniques Create advanced patterns Add draft geometry and symbols to drawings Use layers in drawings to control the display of views and detail items Creating and using tables in drawings

Target Audience: Mechanical Designers, Design Engineers and related roles

Pre-requisite: Introduction to Creo Parametric 2.0 Update to Creo Parametric 2.0 from Creo

Elements/Pro.


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Minitab Non-Normal Data Analysis


Topics include: 1-, 2-, and multi-sample Non-Parametric Confidence Intervals and Hypothesis

Tests, Parametric and Nonparametric Distribution Analysis, Estimation and Demonstration Test

Plans, Acceptance Sampling Plans for Continuous and Attribute Data


Use Non-parametric confidence intervals and hypothesis tests appropriate for non-normal data comparisons.

Explore the common distributions used to model non-normal data—often associated with failure modes–and develop necessary skills in choosing these distributions.

Determine non-normal distribution characteristics of a product using both graphical and quantitative analysis methods.

Determine sample sizes for estimating percentiles, and non-normal hypothesis tests.

Compare and select Acceptance Sampling Plans to ensure appropriate lot inspection and rejection criteria.


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Mistake Proofing


The best way to prevent defects is to examine the process, determine the conditions leading to

those defects, and control those conditions. Mistake proofing devices and techniques can prevent

or minimize errors or defective operating conditions. This course teaches engineers, managers,

technicians and operators how to develop and implement mistake proofing techniques that can

be used to avoid or control defects in daily operations.


Define mistake proofing

Articulate the importance of mistake proofing in manufacturing

Recall types of human error and system error

Distinguish the difference between procedural controls and engineering controls

List types and examples of mistake proofing devices

Identify when mistake proofing should be applied

List the steps for mistake proofing

Apply mistake proofing principals to a given scenario


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PathWise Investigations and CAPA


The PathWise Investigations & CAPA training course is designed to meet the requirements

mandated by world regulatory bodies to effectively investigate and locate causes and correct

them. The attendees will learn how to properly identify non-conformances (problems), how to

assess and prioritize them based on risk, and how to implement a proper corrective and/or

preventive action.

Upon completion of this course, you will learn how to:

Minimize repeat investigations.

Reduce length and number of investigations.

Identify true root causes.

Pinpoint root causes using facts instead of guesswork or opinion.

Avoid costly experiments and trial fixes by logically testing possible causes.

Assess and prioritize each Event based on risk.

Target potential problems before they happen and develop actions to prevent them.

Check effectiveness of corrective actions in the CAPA system.


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Location: Irvine/Draper Duration: 2 Days Investment: $800

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PathWise Technical Writing


Day 1 Required for all to attend: Through the knowledge gained in this course, the attendees will gain insight into the following:

Understand what the FDA and world regulatory bodies expect

How to write for multiple audiences who will be reading the document

Document design and control and the quality of technical writing

Documentation alignment

Explain regulatory requirements with respect to your organization

Write clear, concise, and cohesive documents


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Day 2-3 you can choose from:

Writing Validation Documents


Considerations of Writing Validation Documents



Validation Document Planning

What makes a good Validation Master Plan, Protocol, Report

And/Or

Writing Standard Operating Procedures (SOPs)


Considerations when writing SOPs



Clear and Concise Steps

Planning your document

And/Or

Documenting Investigations


Considerations when Writing Investigation Reports



Getting to a Sound Problem Statement

Creating specific Root Cause and CAPA Statements

Creating Stand-Alone Documents


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Location: Irvine Duration: 1- 3 Days Investment: $600/day

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Process Validation


The purpose of this course is to provide an introduction to the fundamentals of process validation,

explaining how, when, where and why one should validate. Students learn the value of executing

a validation strategy early in the product development process and how this results in robust

processes and delivery of consistent product to the customer. Students receive an in-depth

training on the template-based validation process which facilitates protocol and report writing to

ensure consistency throughout the organization. By the end of this course, participants will learn

how an effective process validation system is a critical requirement to the movement toward a

risk-based approach to compliance and product safety.


Identify the basic objectives of process validation

Define key terms and definitions associated with process validation

Describe the purpose of process validation

Identify the general process validation workflow

Reference the associated regulations and global standard operating procedures for process validation

Determine and complete the requirements for equipment qualification and process validation


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Location: Irvine Duration: 3 Days Investment: $600



When engineers design, we must have a standard way to convey what we are designing so that someone producing our designs will understand with 100% confidence what it is we have drawn. Thinking in the language of engineering graphics, you will visualize problems more clearly and will use graphic images to find solutions with greater ease.


Identify the elements of a drawing sheet & text drawings (off-the-shelf)

Identify line styles that are used in drawings


Determine measurements for objects drawn on orthographic projections and associated views (sectional, auxiliary, and detail)

Identify general notes guidelines

Properly document threads




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Risk Management/FMEA


Can you demonstrate your understanding of the Edwards Risk Management program when your

next inspection occurs? Without comprehensive understanding, you are open to FDA inspection

and submission problems as well as possible enforcement action.

This course introduces the elements of the Risk Management program: identification,

assessment, and prioritization of risks. It includes discussion of appropriate resources to

minimize, monitor, and control the probability and/or impact of unfortunate events or to maximize

the realization of opportunities.







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Root Cause Analysis


Root cause analysis is a general approach to problem investigation regardless of product

category or problem type. This investigation method is used to address a problem or non-

conformance, in order to get to the root cause of the problem. It is used to correct or eliminate the

cause and prevent the problem from recurring.


Apply practical theory of root cause analysis as a problem solving technique to improve a process

Identify the five stages of the root cause analysis procedure and understand how these stages serve as a methodical approach to problem solving

Demonstrate the application of key tools available for problem solving

Differentiate among the root cause analysis tools based on which tool is appropriate for each stage

Demonstrate proficiency in using SOP6221 to perform a root cause analysis through a scenario-based exercise


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Statistical Process Control (SPC)


Offers an overview of SPC, including a short history, types of data and the variety of charts

available for performing Statistical Process Control.


Identify types of data used in SPCs

Distinguish between special cause and common cause variation

Map out and interpret SPC chart data

Determine the appropriate type of SPC chart to use based on given scenarios


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Train the Trainer


Driving Effective Learning: provides an overview and practical application on how to develop

and deliver impactful training that is interactive and engaging. Topics covered include: adult

learning principles, the phases of learning, the instructor’s roles and responsibilities, managing

difficult participants, and designing effective training content.


Identify the techniques for opening and closing the class

Define basic adult learning styles


Define the instructor’s role as a facilitator and trainer

Successfully apply presentation techniques

Manage discussions in a productive and balanced way

Identify common participant types

Effectively handle difficult participants

Use the ADDIE Model (Analysis, Design, Development, Implementation, and Evaluation) to design training content

Target Audience: Anyone who may be designing, developing or delivering training

Location: Irvine Duration: 1 to 2 Days Investment: $300

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ON-DEMAND TECHINCAL CURRICULUM

EDWARDS RAPS ONLINE UNIVERSITY

Offers unique curricula to round out your regulatory knowledge and provide skills with a focus on

medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding

of the regulated health product industry or bolster your credibility and resume or curriculum vitae,

the Regulatory Affairs Certificate is a valuable resource in your pursuit of professional

advancement.

Regulatory Affairs Certificate: Medical Devices

Regulatory Affairs Certificate: Pharmaceuticals

Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)

The curricula are designed to flex to suit your educational needs. These exclusive certificates are

achieved by completing a series of customizable online courses, with an emphasis on medical

devices and/or pharmaceuticals


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Location: Irvine Duration: 2-3 hours Investment: $0

Global Regulatory Strategy for Medical Devices

Course ID: QRC16

The medical device market changes frequently in terms of technology, risk potential, marketing

and reimbursement. Therefore, it is imperative for regulatory professionals to be aware of existing

requirements and new developments in the global market. This course is intended to teach

participants to ask the right questions and adapt the course concepts within their own

organizations.

Upon completion of this course, participants should be able to:

Describe the elements impacting the definition and classification of medical devices

globally

Determine the points to consider in the development of a global regulatory strategy

Define the tools for global regulatory strategy development

Recognize sources of regulatory and competitive intelligence

Identify the elements of a regulatory plan

Apply global regulatory principles to develop a regulatory plan, including STED documents for global registrations.

Target Audience: R&D, Engineering, RA, QA, Clinical, Manufacturing, Sales, Packaging,

Labeling, Advanced Technology

Location: LMS Duration: 4 hours Investment: See RAPS course schedule

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Good Clinical Practices (GCPs)

Course ID: QRC17

Good Clinical Practices (GCPs) are an international ethical and scientific quality standard for

designing, conducting, recording and reporting clinical trials that involve the participation of

human subjects.


Discuss the purpose of Good Clinical Practices (GCPs)

Summarize the history and development of GCPs

Explain the importance of informed consent to the clinical research process

Determine how GCPs affect different clinical development activities

Identify the similarities and differences between US Food and Drug Administration (FDA)

regulations and International Conference on Harmonization (ICH) GCP guidelines

Outline the roles and responsibilities of sponsors, investigators, Institutional Review

Boards (IRBs)/Independent Ethics Committees (IECs) and Independent Data-Monitoring

Committees (IDMCs)




Good Laboratory Practices (GLPs)

Course ID: QRC18

You may read the term Good Laboratory Practices (GLPs) and assume it covers all laboratory

activities, but this is not the case. GLPs are the minimum standards for the proper conduct of

safety testing in a nonclinical environment. They contain principles for managing and operating

laboratory testing facilities involved in the early development process of new chemicals and

substances in order to understand and control their properties so they can safely be tested in, on

or around humans.


Explain the purpose of GLPs

Define the major GLP regulatory systems

Describe the types of studies to be conducted under GLPs

Explain the relationship of GLPs to an overall quality system

List key areas of emphasis under the FDA, EPA and OECD for GLPs




36

Good Manufacturing Practices (GMPs)

Course ID: QRC19

Good Manufacturing Practices or GMPs is a term recognized worldwide for the control and

management of manufacturing and quality control of active pharmaceutical ingredients, foods,

pharmaceutical products and medical devices. GMP regulations and guidance documents are

designed to ensure that products are consistently produced and controlled to quality standards.


Describe GMPs and why they exist

Define quality and state the reasons it is important

Identify the parts of a quality system

Discuss the role of the quality unit

Define the guiding values of the GMPs

Identify and explain significant events that prompted GMP regulation

Identify key sections of the GMP regulations for the US and Europe

Distinguish between different types of inspection and enforcement activities




Medical Devices: Canadian Regulations

Course ID: QRC21

Medical devices are regulated by Health Canada under the Food and Drugs Act and the Medical

Devices Regulations (MDR). Under the MDR all devices must meet safety and effectiveness

requirements and must have a compliant label before they can be imported into and/or sold in

Canada. Classes II, III, and IV will require licensing and a Medical Device Establishment License

(MDEL) may be required


Discuss the regulatory framework for medical devices in Canada

Evaluate the appropriate classification of medical devices

Identify the regulatory requirements for an Investigational Testing Authorization (ITA), a

Medical Device License (MDL) and a Medical Device Establishment License (MDEL)

Discuss the requirements of quality systems for medical devices

Explain the Medical Device Inspection Program



Location: LMS Duration: 1 hour Investment: See RAPS course schedule

37

Medical Devices: China, Japan, Singapore and South Korea Regulation

Overview

Course ID: QRC22

Navigating global regulatory markets in Asia can be a challenge, particularly when each country

has unique regulations and requirements. Every country has its own body or system of legal

requirements for placing medical devices in the market. Therefore, comprehending the various

Asian laws and regulations is the key to registration of products. This course examines and

introduces medical device regulations and registration in China, South Korea, Japan and

Singapore.


Discuss medical device regulations in China, South Korea, Japan and Singapore

Apply practical guidance on how to comply with the requirements

Describe how these requirements are being interpreted and applied in these rapidly growing markets

Implement quality system/Good Manufacturing Practices (GMPs) requirements that comply with the medical device regulations

Define product registration strategies and define labeling requirements for medical devices in the Asian markets

Identify documentation required for application and approval of medical devices in China, South Korea, Japan and Singapore




Medical Devices: Compliance and Audits

Course ID: QRC23

Auditing is a reality in the world of medical devices. It has many facets, including, but not limited

to, first-party, internal, second-party, supplier, external, US Food and Drug Administration (FDA),

ISO, etc. Regardless of the audit’s nature and scope, the outcomes are basically the same.

Typical audit outcomes involve some sort of action to come into compliance with standards or

regulations and make improvements to quality management systems.


Prepare and conduct an audit and audit close-out meeting

Develop the records required to document audit activities

Describe auditing techniques, useful tips and methods employed by skilled auditors to get at underlying issues or to assure compliance




38

Medical Devices: Corrections, Removals and Directed Recalls

Course ID: QRC24

Medical device recalls are a difficult aspect for medical device manufacturers and distributors,

and most importantly, with the end users of these devices. Balancing the needs of the users

along with the various regulatory requirements creates challenges for those responsible for

deciding and executing recalls. A medical device recall does not always mean that you must stop

using the product or return it to the company. It sometimes means that the medical device needs

to be checked, adjusted, fixed or provided with additional labeling to ensure the safe and effective

use of the product. This course examines compliance with US FDA, Health Canada, and

European Union requirements and regulations.


Determine what actions are taken in a medical device recall

Cite the regulatory requirements for recalls/ field actions regarding medical devices

Reference and use medical device recall authority and guidance documents

Identify and understand the applicable regulatory standards and guidance documents

Discuss what is required for the recall strategy as expected by Health Authorities

Identify the different recall types and classifications

Explain what types of communications are required

Define what effectiveness checks are

Outline the steps required to terminate a recall and what regulatory reports and records

are required for a device recall




39

Medical Devices: Definition and Lifecycle

Course ID: QRC20

Medical devices go through a long and complex process of development before being made

available for therapeutic or diagnostic use. This process involves professionals from varied

backgrounds, such as scientists, clinicians, regulatory specialists, legal experts and business

specialists.


Provide the definition of “medical device”

Describe how medical devices are classified

Outline the activities within a medical device’s lifecycle phases

Discuss different types of medical device marketing authorizations




Medical Devices: EU Regulations

Course ID: QRC25

Medical device manufacturers face global economic challenges in an ever-changing regulatory

environment. These changes come in the form of more stringent and complex regulations, higher

patient expectations and commercial pressures. As the regulatory profession continues to grow in

importance and prominence, regulatory professionals have become key contributors to a

company’s ability to devise successful business strategies and execute these strategies

effectively. Therefore, they need to build robust regulatory expertise by continuously sharpening,

maintaining and expanding their skills, knowledge and understanding of relevant and applicable

regulations and emerging technologies.


Explain the differences among the scopes of the three EU device directives

Outline how medical devices are classified using the European regulatory framework

Identify the important elements of each EU directive

Discuss the general requirements of preclinical and clinical testing in Europe

Describe the conformity assessment pathways for obtaining CE mark

Cite the key requirements for post-marketing surveillance

Explain the overall regulatory requirements for medical devices in the EU




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Medical Devices: Postmarket Surveillance

Course ID: QRC27

Regulatory authorities allow medical devices to be placed on the market based on data

supporting the reasonable assurance that the proposed device is both safe and effective. These

data comprise prospective premarket information generated by using ideal devices under ideal

conditions. Retrospective postmarket data derived from devices and conditions may differ from

the premarket testing in ways both obvious and subtle. An effective postmarket surveillance

program monitors the performance of the full range of actual devices under all actual usage

conditions, to ensure that the assumptions and estimates applied during the product development

process were accurate and remain so throughout the total product lifecycle.


Describe the role of a postmarket surveillance program on device safety, efficacy, risk

management and product development

Define the regulatory and quality system requirements that address postmarket

surveillance in the US, Canada and Europe

Describe the sources of postmarket surveillance data and their relative strengths and

weaknesses

Outline methods for analyzing postmarket surveillance data.

Identify the various actions that can result from the collection and analysis of postmarket

surveillance data




41

Medical Devices: Risk Management

Course ID: QRC28

Risk management is a process for identifying, evaluating and mitigating risk. For medical devices,

this means product safety, including risks associated with harm to people and damage to property

or the environment. Risk management has become an integral part of medical device design and

development, production processes and evaluation of field experience. Risk management is

applicable to all types of medical devices and evidence of its application is required by most

regulatory bodies.


Utilize risk management techniques to assess risk, including postmarket risk

Define risk management terms and concepts

Identify risk management guidance documents and standards

Explain how risk management is integrated into design control, production and post-production

Outline the application of risk management throughout the product lifecycle




Medical Devices: US Regulations

Course ID: QRC26

The commercialization of food and drug products has been regulated in the US since the early

20th century. Passage of the Pure Food & Drug Act of 1906 was partly prompted by the

publication of Upton Sinclair’s famous work, The Jungle, which described in detail many horrors

associated with the American meatpacking industry at the time. Passage of this legislation paved

the way for development of the landmark Food, Drug, and Cosmetic (FD&C) Act, which was

signed into law in 1938. The objective of the FD&C Act was to ensure the safety of drug products

commercialized in the US and the law was a major step forward in regulating products used in

clinical settings.


Define a medical device and understand FDA regulations surrounding commercialization

Understand FDA interaction within the agency itself, with other US government agencies and with device manufacturers

Describe types of device submissions, their requirements and uses and how to select the most appropriate one

Describe and explain the regulation of advertising, promotion and labeling

Understand postmarketing requirements, including those sometimes imposed by FDA, as a condition of marketing approval




42

Regulation of Combination Products

Course ID: QRC29

Combination products have the potential to offer novel alternatives for patient care because the

unique combination of drugs, medical devices and/or biological products produces therapeutic or

diagnostic results not seen when they are used independently. However, development of

combination products creates challenges in defining specific regulatory requirements because the

constituent parts are regulated using different regulatory standards by different FDA centers—

Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research

(CBER) and Center for Devices and Radiologic Health (CDRH).


Define key terminology, such as drug, device and biological product, and explain how those definitions help form the basis for the definition of a combination product

Describe how a primary mode of action (PMOA) is determined and its role in establishing which FDA center will have primary jurisdiction for the review of a combination product.

Identify the type(s) and number of investigational and marketing applications that may be filed for a combination product, and the associated user fees

Explain the importance of, and prepare and implement a strategy for educating, communicating and interacting with FDA throughout the regulatory process

Discuss some of the unique challenges of fulfilling premarket requirements for combination products and identify existing guidance and regulations in this area

Discuss the scope of GMP requirements for combination products, requirements for post market safety reporting and inspection and enforcement.




43

Quality System Regulation (QSR)

Course ID: QRC30

Every medical device manufacturer must establish and follow a quality system to help ensure that

its products consistently meet applicable requirements and specifications. The quality systems for

US Food and Drug Administration (FDA)-regulated products (food, drugs, biologics and devices)

are known as current good manufacturing practices (CGMPs). CGMP requirements for devices

are outlined in 21 CFR, Part 820.


Discuss the QSR in terms of application and requirements of a medical device company for designing, manufacturing, packaging and distributing medical devices.

Cite the requirements for a quality management system that a medical device manufacturer must establish and implement.

Apply the requirements mandated by FDA for medical device manufacturers to the different processes within the organization.

Explain the basics of implementing a quality system and interpreting the QSR for practical application for the organization.

Identify the different procedures, work processes and quality records that must be generated to support an inspection by FDA.




Regulation of IVDs in the US

Course ID: QRC31

In vitro diagnostic (IVD) products drive a significant portion of clinical decision making today. IVDs

assist in the identification, diagnosis and monitoring of disease. They play an ever-expanding role

in the selection of appropriate therapeutic interventions in healthcare delivery with the advent of

personalized medicine. These key products are a distinct class of medical devices regulated in

the US by the Food and Drug Administration (FDA).


Discuss the current state of IVD regulations in the US and other regions

Identify and explain areas of IVD regulations related to product classification

IVD development, testing and premarket submission, postmarket maintenance and considerations for users of the IVD product

Identify potential future challenges facing IVD manufacturers

Discuss IVD technologies and emerging trends

Apply IVD-specific regulations and guidelines for successfully traversing regulatory hurdles




44

Understanding and Managing US Clinical Trial Process

Course ID: QRC32

Clinical trials are an essential part of the evaluation of safety and efficacy for new drugs, biologics

and medical devices, and are critical to obtaining regulatory approval as the final milestone in

product development. As a regulatory professional, you have a significant role in clinical trial

management, so it is imperative that you understand the clinical research process and basic

issues associated with the infrastructure elements required for the successful management of

clinical trials.


Discuss the history and evolution of clinical trials

Identify the importance of informed consent to the clinical research process

Describe the major requirements in each applicable Code of Federal Regulations (CFR) section related to clinical research

Outline the steps of clinical trial development and execution

Distinguish between different types and phases of clinical trials

Outline the roles and responsibilities for conducting clinical trials

Describe the regulatory issues related to data management during a clinical trial




45

Supply Chain

46

This course will walk you through our S&OP Processes (Demand & Supply Planning) and train

you on the associated tools.

Upon completion of this course, you will have an understanding of:

Explain the S&OP Process – which forms the context for the JDA Planning and QV Reporting

Perform the maintenance activities for JDA Demand and JDA Supply

Perform the day to day planning activities using JDA Demand and JDA Supply

Be able to support other planners and play a superuser role and play lead role in projects

Be aware of available QV and Cognos reports

Navigate and interpret the available reports.

Target Audience: Regional Demand Planners, Regional Supply Planners, Master Schedulers,

Production Planners, Operations Planners

Location: Irvine, CA Duration: 4 Days Investment: $0

S&OP Process/Tools for Experienced Users (JDA/QlikView)


47

College of Sales & Marketing

48

Healthcare Economics & Policy Program

Course ID: MDP10004

Taught by Dr. Lawton Burns, this 2-day course has been designed to provide participants with an

increased understanding of the current business operating environment for hospitals, evaluation

of hospital economics, and the increased push for transparency within these discussions.

Upon completion of this course, participants will be able to understand:

Brief history to date of the Healthcare sector covering all stakeholders in the full continuum of care.

Assessment of where the Healthcare industry is headed within the next 5-10 years as it relates to each stakeholders interactive role, position and financial impact.

Hospital/ Physician Collaboration: Impact of Economic & Clinical Integration

Formation of Hospital Systems & Potential Implications

Views on the impact the “Rest-of-world” will have on US Healthcare Economics (China/India, austerity measures, privatized/socialized care).

The Economics of Pricing Transparency

The Evolving GPO/IDN Marketplace: The Rise of Regional Purchasing Coalitions as GPOs within national GPOs/ IDN consolidation.

Examples of Best of Practice Medical Device Companies who are winning with Hospitals, Physicians and GPOs in this Era of Healthcare Reform.

Target Audience: Sales Representatives

Location: Varies Duration: 2 days Investment: $0

Hospital Financial Acumen

Course ID: NAS10026

This course is designed to partnership with the Aarthun Performance Group, delivered in a highly

interactive format, to focus around overall financial acumen to understand and deal with the

challenges and opportunities our hospital customers are currently facing in the shifting landscape

of healthcare.

Upon completion of this course, participants will be able to:

Increase the ability to interpret primary financial statements (Balance Sheet/Income Statement/ Cash Flow) through the lens of a hospital / hospital system.

Understand the overall economics of the customer's business and the factors that drive profitability

Learn how to identify what Effort & Return means to the decisions the key hospital stakeholders make

Connect to the customer's key financial drivers and performance metrics

Increase the ability to quantify and sell the value of solutions

Minimize the competitive threat by competing on improved value as opposed to price


Location: Varies Duration: Varies Investment: $0

49

Leading Amidst Change

Taught by professor and author, Dr. Lawton Burns (UPenn, Wharton School of Business)

Course ID: SMT10053

This course provides a strong focus on leadership skills as it relates to the current evolution of our

healthcare environment. It is designed to help people to be prepared to adapt to the level and

rate of change within the healthcare industry and be able to Lead Amidst Change. The course will

consist of case studies and real-time discussion of the attendees’ experiences.


Explore the importance of staying relevant and on top in our changing industry.

Explore a list of top challenges expected in the coming 24 months

Identify the traits/characteristics needed to be successful and to continue to lead

Gain the expanded perspective to apply towards driving results within your key accounts and core customer



Negotiation Skills- Introduction Workshop

Taught by Harvard Law Professor Bob Bordone

Course ID: MDP10001

This course is the Part I (Introduction) of the Negotiation Skills Workshop and is designed to

provide a formal working definition of negotiation and identifies the typical challenges and

difficulties often faced when we negotiate. It also offers broad strategies for effectively managing

these challenges and improving one’s skills as an effective negotiator.


Utilize the “Seven Critical Elements of Negotiation Success” and several other negotiating tools and concepts to improve one’s ability to deal effectively with negotiation challenges as they arise in the course of a deal or dispute.



50

Advanced Negotiation Skills Workshop

Taught by Harvard Law Professor Bob Bordone

Course ID: MDP10008

This course is the Part II (Advanced) of the Negotiation Skills Workshop and is designed to

provide further support of negotiation skills. Edwards Case Studies, based on scenarios that are

typically encountered in the field, will be incorporated throughout the course to facilitate group

discussion.


Identify strategies in navigating negotiation with our expanded hospital stakeholder base, including conversations with hospital administrators and other key decision makers within an account.

Conduct discussions with a hesitant or resistant customer base, ease tension, and find common grounds of agreement.

Target Audience: Sale Representatives

Pre-requisite: Negotiation Skills – Introduction Workshop


51

Cardiac Surgery Systems

52

CSS Advanced Course

Course ID: CSS10006

The CSS advanced course provides the participants an understanding of MIVS products

including:

Instrumentation

TEE education, Fluoroscopy training, Best selling strategies for MIVS

MIVS procedures including right thoracotomy MVR, Upper sternotomy AVR and right thoracotomy AVR cardiac physiology

Target Audience: New hires as well as those interested in minimally invasive products and

procedures

Location: Draper Duration: 3.5 days Investment: $0

CSS Fundamentals Course

Course ID: CSS10007

The CSS fundamentals course provides the basic knowledge of:

Cardiac, vascular and thoracic anatomy

Cardiac physiology

Risk factors

Heart and thoracic pathology and treatments

EPC product line training

Introduction to MIVS

Target Audience: New hires as well as anyone who may be interested in learning more about

our EPC product line

Location: Draper Duration: 3 days Investment: $0

53

Critical Care

54

Anatomy and Physiology

Course ID: GHR10020

This course covers a big picture of the anatomy and physiology of the cardiovascular system.


The Anatomy of the heart: The cardiovascular system, location of the heart, heart valves and chambers, heart valve anatomy, blood flow through the heart, explore the heart, components of blood, vasculature and circulation, explore the cardiovascular system, heart physiology, measuring cardiovascular function.

The Heart Physiology- The electrical conduction system that stimulates heart contraction, the phases of the cardiac cycle, and the hemodynamics.

Note: Please be advised to use Internet Explorer 8 or FireFox in order to view the

Anatomy and Physiology eLearning Module

Target Audience: Critical Care Personnel

Location: LMS Duration: Varies Investment: $0

ClearSight Limited Launch Training Course

Course ID: CC10077

The course comprises of eLearning modules, animation, simulations and read and review documents. In addition to this, there will be a requirement to successfully complete the hands on workshop as part of the January 2014 sales force meeting. THESE MATERIALS ARE FOR INTERNAL USE ONLY AND NOT FOR EXTERNAL DISTRIBUTION.

ClearSight Module One - How It Works

ClearSight Module Two - Setup

ClearSight Module Three - Finger Reactions

Upon completion, you will be able to:

Prepare sales personnel for the limited launch of the Clear sight / EV1000NI in Europe.

Target Audience: Critical Care Sales Personnel

Location: LMS Duration: 3 hours Investment: $0

55

Edwards Vigilance II

Course ID: CC10065

This course introduces the Edwards Vigilance II monitor, an integral part of the Edwards

Advanced Technology Hemodynamic Monitoring System which uses the Advanced Technology

Swan-Ganz catheter.

Upon completion of this course, you should be able to understand the basic knowledge

necessary for operating the Vigilance II monitor. You will learn:

Navigation controls and connectors

Descriptions of the layout of the monitor screen

Procedures for start-up, calibration, and operation of the monitor

Instructions for configuring the Vigilance II monitor

Description of the specialty operations of the monitor



EV1000 Simulator Training

Course ID: CC10081

This course features a series of videos demonstrating the use and functionality of the EV1000

Edwards Lifesciences simulator.

Edwards Simulation Training Lesson 7: EV1000 Simulation Program Functionality with VolumeView

Edwards Simulation Training Lesson 8: EV1000 Simulation Program Functionality with Oximetry

Edwards Simulation Training Lesson 9: EV1000 Simulation Program with Heart Rhythms

Edwards Simulation Training Lesson 10: EV1000 Simulation Program using A-fib, PLR and PEEPUpon completion of this course, you should be able to understand the basic knowledge necessary for operating the Vigilance II monitor.

Target Audience: Critical Care Sales Personnel

Location: LMS Duration: 4 hours Investment: $0

56

The EV1000 Clinical Platform

Course ID: CC10050

This EV1000 clinical platform presents the physiologic status of the patient in an entirely new,

intuitive and meaningful way. The EV1000 supports Edwards FloTrac, VolumeView and PreSep

technologies.

Upon completion of this course, you should be able to understand:

Setup and configure the EV1000 monitor

Set up and calibrate the FloTrac sensor

Set up and calibrate the VolumeView sensor

Set up and calibrate PreSep Oximetry catheter



The FloTrac System

Course ID: CC10052

The course covers the topics of: Calculating Cardiac Output with the FloTrac System, the FloTrac

System Limitations, Troubleshooting the FloTrac System, and the Clinical Applications.

Upon completion of this course, you should be able to:

Understand how the FloTrac algorithm calculates cardiac output

Identify the limitations of the FloTrac system

Identify the methods for troubleshooting

Review current FloTrac system accuracy

Recognize clinical applications of the FloTrac system



57

The Intravascular Monitoring and Set Up with TruWave Transducer

Course ID: CC10055

This course covers the steps to be carried out for setting up the TruWave system.

Upon completion of this course, you should be able to perform the six steps:

Set up transducer kitusing aseptic technique

Mount TruWave Transducer

Prime the TruWave transducer

Pressurize infuser bag

Level and Zero the TruWave transducer



The Oxygen Delivery (DO2) and Oxygen Consumption (VO2) Concepts

Course ID: CC10056

This course reviews the basic concepts of oxygen delivery (DO2) and oxygen consumption (VO2),

the implications of an imbalance between delivery and consumption, and the monitoring tools

available to the clinician


List the components of oxygen delivery (DO2)

Describe the importance of the balance between DO2 and VO2

Identify factors that may contribute to an imbalance

Describe the tools available to clinicians to monitor the balance between DO2 and VO2



58

The Stroke Volume Variation (SVV)

Course ID: CC10058

In this course, the following topics will be covered: The Overview of Stroke Volume Variation

(SVV), SVV and Preload Responsiveness, and The Applications and Limitations of SVV.


Define stroke volume variation

Identify how SVV is calculated

Identify SVV during normal breathing versus mechanical ventilation

Determine why there is a difference in SVV during normal breathing versus mechanical ventilation

Define preload responsiveness

Identify the limitations of SVV



The TruWave Transducer

Course ID: CC10059

This course covers the Disposable Pressure Transducers - Clinical Application, Technologic

Principles, Setup and Maintenance, and Trouble Shooting of the TruWave transducers.


Identify the clinical applications of disposable pressure transducers and technologic principles

Recognize the parameters generated from intravascular monitoring, specifically arterial pressure monitoring

Identify basic TruWave pressure transducer kit and cable configurations

Recognize the process for setting up and calibrating a transducer system

Identify how to troubleshoot a transducer system



59

The VAMP Adult System

Course ID: CC10060

The VAMP Adult system, designed to be used with adult patient at bedside- for closed needleless

blood sampling in the ICU to enhance blood conservation and infection control. .


Benefits of a closed needleless blood sampling vs. traditional sampling

How to set up and prime the VAMP system

How to draw and sample from the VAMP system using a syringe

How to draw and sample from the VAMP using a vacutainer

How to use a blood transfer unit (BTU)



The VAMP Flex System

Course ID: CC10061

The VAMP Flex system-designed to be used for closed needleless blood sampling in the adult

patient in the operating room (OR) or in intensive care unit (ICU) to enhance blood conservation

and infection control.









60

The VAMP Junior System

Course ID: CC10062

The VAMP Junior System, designed for closed needleless blood sampling in the pediatric and

neonatal patients to enhance blood conservation and infection control in the OR or ICU.









The VAMP Plus System

Course ID: CC10063

The VAMP Plus System, designed to provide closed needleless blood sampling in the OR or ICU

to enhance blood conservation and infection control.









61

The Venous Oximetry

Course ID: CC10064

This course will cover the topics of: Physiology of Oxygen Delivery and Consumption, Venous

Oximetry, Fiberoptic Oximetry Catheter Technology, and Clinical Application of Venous Oximetry.


Describe the components of oxygen delivery and consumption

Identify the different types of oxygen saturation.

Identify causes and effects of inadequate oxygen delivery

Recognize venous oximetry as a more sensitive method of monitoring the balance of oxygen delivery and consumption than traditional vital signs

Distinguish the similarities and differences between SvO2 and ScvO2 monitoring

List the four physiologic components that affect venous oximetry

Identify the types of venous oximetry fiberoptic catheters



The Vigileo Monitor

Course ID: CC10066

The Vigileo monitor is an integral part of the Edwards minimally invasive hemodynamic

monitoring system. This is to be used in conjunction with the Edwards FloTrac sensor and

Edwards oximetry catheters.


The basic knowledge necessary for operating the Vigileo monitor, the FloTrac sensor and oximetry catheters

The navigational controls and basic operation of the monitor and preparation of the monitor for cardiac output and oximetry monitoring

Various data being output during operation



62

The VolumeView System

Course ID: CC10068

The VolumeView System (VVS) expands the application of the Thermodilution Technology to

enhance the patient care through Transpulmonary Thermodilution Technology (TPTD). The VVS

uses the similar concepts


Understand the how VolumeView assists in the assessment of the balance between oxygen delivery and consumption

Understand the how VolumeView measures cardiac output using Transpulmonary Thermodilution (TPTD)

How VolumeView calculates Global End Diastolic Volume (GEDV)

How VolumeView calculates Global Ejection Fraction (GEF)

How VolumeView calculates ExtraVascular Lung Water (EVLWI)



63

Heart Valve Therapy

64

Employee Case Observations

Course ID: HVT10032

The HVT Education offers a list of centers where Edwards’ employees may observe live surgery.

This is an excellent way to learn firsthand, in a real-life setting, how Edwards’ products work.

Surgeons participating in this program are all highly skilled and excellent teachers. Courses

offered are included in the link below:

http://team/hvt/HVTProfEdLibrary/AnatomyPhysiology/Forms/AllItems.aspx


Come in and learn from them from the ground up

Learn firsthand, in a real-life setting how Edwards’ products work

Please contact Patsy Bargas at X3653 for additional questions and registration

Target Audience: Sales, Marketing, R&D, RA, Operations, Quality, Clinical Affairs

Location: Varies Duration: 4-8 hours Investment: $1,000-$2,500

HVT Basic Training

Course ID: HVT10013

The HVT Basic Training program is an open forum to help new employees learn about Edwards’

industry and the surgical procedures. Attendees will learn about Edwards’ product portfolio from

subject matter experts and appropriate use of our products in medical practice from key opinion

leaders. Courses offered included:

An overview of cardiovascular anatomy and physiology and in-depth analysis of valvular structures

Cadaver heart anatomy wet lab

Hands-on pig heart anatomy wet lab

Hands-on pig heart valve and ring implantation wet labs

Didactic training on valve disease, diagnosis and treatment options

Didactic and practical applications of echocardiography

Advanced imaging (echocardiography, angiography, CT, etc.)

How and why to drive adoption of the valve clinic model

HVT product training including marketing messaging and sales tools

In-depth presentations from Edwards’ Quality, R&D, Compliance, Regulatory and Health Care Economics Departments

Several panel discussions with experienced HCPs and Edwards field reps


Take the knowledge they gain from the course and apply it directly to their careers

Obtain benefit from the ample networking opportunities provided by the course

Target Audience: Sales, Marketing, R&D, RA, Operations, Quality, Clinical Affairs

Note: Basic I and Basic II may be taken out of order. New employees should register for

whichever course is offered first.


http://team/hvt/HVTProfEdLibrary/AnatomyPhysiology/Forms/AllItems.aspx

65

Transcatheter Heart Valve

66

ACC2011: Clinical Trial Design and the Edwards Transcatheter Heart Valve

Clinical Program

Course ID: THV10044

This e-learning course covers general clinical trial design information and how the PARTNER trial

design fits within Edwards.

Target Audience: THV personnel


ACC2011: The PARTNER Trial: Overview and Design - Cohort B Results

Course ID: THV10045

This e-learning course covers Transcatheter vs. Surgical AVR in High Risk Patients with Severe

Aortic Stenosis.



CT for TAVR Video

Course ID: THV10046

This is a video course, presented by Dr. J. Leipsic, St. Pauls Hospital to illustrate the utility of CT

for TAVR.



Echo for TAVR Video

Course ID: THV10047

This is an In-depth video overview of the role of TTE, TEE in TAVR by Dr. Rebecca Hahn,

Columbia University Medical Center.



67

Patient Video, Logistics- Own the Moment Video

Course ID: THV10041

This e-learning course covers the media moments and the launch of Sapien THV



Retroflex 3 Patient Screening e-Learning

Course ID: THV10043

This e-learning course covers:

Aortic Stenosis

The Valvular Complex and Anatomic Suitability: Access Vessels, the Arch and Coronaries



Structural Heart Anatomy Course

Course ID: THV10042

This video learning course comes from Cardiac Anatomy Bioskills Session at TVT Conference

2012.

Dr. Mark Riesman and colleagues review cardiac anatomy and its interaction with CoreValve and

SAPIEN THVs.



68

Leadership Development

Center of Excellence

69

ASPIRE CURRICULUM - OPEN ENROLLMENT

Critical Thinking

Course ID: ASP10045

Critical thinking is an impartial way of analyzing and evaluating data, statements, and observations. This course covers the use of critical thinking techniques to guide individual decision making, and problem solving. The benefits of critical thinking include the ability to:

Make faster and most likely correct decisions

Provide more innovative solutions to problems, goals, and strategies

Obtain higher quality decisions and actions from individual employees and a more equipped work force that tackles problems and makes decisions on a daily basis.


Distinguish “Automatic” Thinking from “Manual”

Learn and practice a variety of tools to think critically

Be able to ask questions to get yourself and others to think critically

Understand and utilize critical thinking tools.

Create a next steps plan

Target Audience: Individual Contributor, Supervisor, Manager, Director, Vice President

Location: Irvine Duration: 1 day Investment: $1,000

Crucial Conversations

Course ID: ASP10002

Could a conversation (or avoiding one) be keeping you from getting the results you need? Whether the issue stems from poor productivity or declining quality to lack of teamwork or strain relationship, it’s likely that you’re experiencing the effects of a poorly held crucial conversation.

The Crucial Conversations® Training provides high-leverage skills for individuals, teams and organizations that under-communicate, withhold information or fail to act with unity and conviction.

In this course, participants learn how to:

Create conditions where people speak with complete candor and respect

Gain skills that enable spirited dialogue and to reduce deference and defiance.

Step up to tough issues and share opinions, feelings, and information freely


Catch problems early and resolve disagreements candidly and respectfully.

Maximize input from people closest to the work

Express the best ideas in a way that builds acceptance rather than resistance – including challenging the way things are currently being done.

Make better decision and then take more committed action.



70

Finance for Non-Financial Managers

Course ID: ASP10004

This program has been designed by American Management Association to help Edwards’ leaders

reduce the risk of financial errors in managerial decision-making.

Upon completion of this course (program), participants will be able to:

Learn the basic accounting concepts.

Understand the financial statements

Review of Edwards annual report

Evaluate Edwards Lifesciences financial statements

Capital expenditure analysis

Target Audience: Supervisor, Manager and above


Leading Across Generation

Course ID: ASP10080

This program is designed managers and above where you will learn about the four generations in

the workforce today and some of the friction that we experience because of that.

Upon completion of this program, participants will be able to:

Gain an understanding of the specific differences between the four generations in today’s workforce

Understand the “points of friction” where one generations style or perspective is likely to conflict with those of another generation

Target Audience: Managers and above

Location: Irvine Duration: 3.5 hours Investment: $200

71

Leading at Edwards: Your Role and Your Team

Course ID: ASP10070

This program is designed for employees who are new to management, or those moving from an

individual contributor role to a supervisory role.


Understand the role of a leader

Describe your role in managing performance

Learn the annual cycle of EW manager responsibilities

Determine best practices for communicating and cascading information

Apply basic strategies to tailor communication based on the communication styles of direct reports

Target Audience: New Supervisor, Manager and above

Location: Irvine Duration: 1 day Investment: $0

Leading at Edwards: Performance Management and Engagement

Course ID: ASP10071




Delegate to appropriate authority

Learn how to set expectations

Give feedback for reinforcement

Give feedback for improvement

Deliver meaningful recognition

Motivate and inspire your team



72

Leading at Edwards: Learning From Our Leaders

Course ID: ASP10072



Upon completion of this program, participants will learn the essential management processes at

Edwards, which include:

Performance Management, TDR and Success Factors

Managing Compensation at EW

Market-based pay

PayREVIEW

Promotions

EW Planning Process – Overview of Financials

EW Manager’s Role in Compliance

Manager’s Portal – helpful intranet links for managers



Leading Strategic Execution

Course ID: ASP10048

This is a dynamic two-day experiential learning program that builds a leader’s capability

to make the right decisions better and faster for achieving business results


Discover and differentiate the role and responsibilities of the mid-level leader relative to other leadership levels of an organization

Recognize and reconcile paradoxes in the business environment to resolve competing priorities and optimize outcomes

Identify and assess key stakeholders to influence and strengthen relationships that lead to the acceleration of key business results

Discover how to propel teams through the stages of development to build high levels of engagement and top performance

Build capability to recognize key derailers and take appropriate action to get strategy execution back on course

Target Audience: Manager and Senior Manager


73

Leveraging Diversity

Course ID: ASP10046

This class approaches the topic of diversity from a different perspective to help us in our

competition for the best employees, our ability to innovate, make well-rounded decisions, and

reduce conflict. This program combines small group discussion, short presentations,

assessments and group exercises.

Attendees will focus on the role of the manager in creating a culture of diversity within Edwards.

Upon completion of this course participants will be able to:

Demonstrate the principle that individual distinctions are a source of strength for innovation at Edwards

Become a role model as a manager who leads and leverages diverse teams

Develop and use a set of guidelines for creating a welcoming, inclusive and open team environment

Understand and mitigate the impact of prejudgment and stereotyping on individuals and teams

Reframe negative judgments of team members behavior by assuming best intentions and seeking understanding

Discern when conflict between team members is a result of cross-cultural or cross-personality issues and deal effectively with the issues

Target Audience: Supervisor, Manager, Director, Vice President

Location: Irvine Duration: 4 hours Investment: $0

Presentation Skills – Power Speaking®

Course ID: ASP10010

PowerSpeaking® is an intensive, video based, presentation skills workshop that helps people

become more effective presenters.

Through a “learn by doing” approach and individualized oral, written and video feedback,

participants learn to organize content memorably (substance), deliver their message persuasively

(style) and control their environment and audience respectfully and professionally (staging).This

course provides the skills to effectively delivering presentations to audiences that influence

action, impact performance, and deliver results.


Create a clear, memorable core message

Develop a well organized, systematic presentation so the audience can easily follow along

Incorporate a balance of stories, analogies, and metaphors with data

Project personal confidence and credibility through effective style

Use visual aids effectively

Evaluate individual presentation strengths and areas for improvement

Target Audience: Any Individual Contributor, Manager and above who must be effective

speaking in front of groups


74

Project Management Essentials for the Unofficial Project Manager

Course ID: ASP10073

This training course teaches a five-step process for managing projects. Participants will be

provided with the mindsets, skill sets, and toolsets to consistently produce high-quality projects

that exceed expectations around time, budget, and quality.


Exercise the skills of managing the projects with “informal authority“, so team members are inspired to contribute to project success.

Understand the foundation of project success depends on processes and people, and the need to implement Four Foundational Behaviors that inspire their team members to execute with excellence.

Identify a project's stakeholders and establish clear and measurable project outcomes to create a well-defined project scope statement.

Plan, identify, assess, manage project risks, and create a realistic and well-defined project schedule.

Execute by holding team members accountable to project plans and conducting consistent team-accountability sessions.

Monitor and control by creating a clear communication plan around their project that includes regular project status reports and project changes.

Close the project with rewarding and recognizing the contributions of project team’s members along with formally documenting lessons learned.


involved with project management experience


75

Situation Leadership II

Course ID: ASP10009

Situational Leadership® II (SLII

®) is the most comprehensive, up-to-date, and practical method of

effectively managing and developing people, time, and resources.

SLII® is a model and a set of tools for opening up communication and helping others develop self-

reliance.

It is designed to increase the frequency and quality of conversations about performance and

development between managers and the people they work with to:

Develop competences

Gain commitment

Retain talented individuals.


Learn a common language and create a basis for conversations, use coaching, and action planning

Recognize a variety of leadership styles that are appropriate for all situations and learn to be flexible in applying the styles

Link organization and individual goals in a unified direction

Understand the negative impact of over-supervision and under-supervision on performance and how to avoid a mismatch in style

Learn how to develop motivated and productive team members

Learn how to tailor your leadership style in a way that is most appropriate for the situation

Learn how to effectively direct and support people to reach their performance goals

Learn how to improve communication skills

Target Audience: Executives, Managers at all levels, Project Managers, Team Leaders, and

Supervisors that want to increase their effectiveness will benefit from knowing SLII®


76

The 5 Choices to Extraordinary Productivity Essentials

Course ID: ASP10074

In this time and life management workshop, the participants will learn a process to identify the

opportunities and technologies, to spend time and energy on the most important goals/objectives

and soar to creative and innovative heights.

This course will produce a measurable increase in productivity and an inner sense of fulfillment.


Learn to approach each day with an “important mindset”, to identify and eliminate distracting activities.

Go for the extraordinary –Work to define extraordinary outcomes for your roles to help focus your efforts to measure day-to-day decisions.

Schedule the big rocks – don’t sort gravel. Consistently planning activities around identified “most important outcomes” will create a pattern of focus and success

Rule your technology – don’t let it rule you. Learn rules to maximize the use of platforms such as Microsoft Office in building a reliable personal information system.

Fuel your fire – don’t burn out. Create a plan that will ignite your energy.

Target Audience: Individual Contributor, Supervisor, Manager, Director


77

The 7 Habits of Highly Effective People

Course ID: ASP10008

The 7 Habits of Highly Effective People Signature Program teaches a natural process that helps

transform employees from contributors to true leaders.

This workshop will help the leaders at Edwards develop the skills needed to improve personal

and professional effectiveness, increasing trust and influence in their roles.

The 7 habits are as below:

Habit 1: Be Proactive

Habit 2: Begin with the End in Mind

Habit 3: Put First Thing First

Habit 4: Think Win-Win

Habit 5: Seek First to Understand

Habit 6: Synergize

Habit 7: Sharpen the Saw


Improve results at the personal and professional level

Develop more meaningful relationships, increasing the ability to work both with and through others.

Increase effectiveness and productivity by focusing on the things most important to the organization.

Achieve a healthy work/life balance.



Working Across Generations

Course ID: ASP10081

This program is designed for individual contributors where you learn about the four generations in

the workforce today and some friction that we experience.


Gain an understanding of the specific differences between the four generations in today’s workforce.

Understand the “points of friction” where one generation’s style or perspective is likely to conflict with those of another generation.

Target Audience: Individual Contributors

Location: Irvine Duration: 3.5 hours Investment: $200

78

ASPIRE COURSES- NOMINATION REQUIRED

The prospective participants must be nominated to attend the courses listed below. The course

fee (as applicable) does not apply to participants outside of the US.

Best Management Practices

Course ID: ASP10075

The course is designed to develop managerial skills and knowledge and includes all important

components to a manager’s success at Edwards. Participants meet once per month to develop

competencies and skills in managing and leading people, as well as an action learning

component so that they will apply the principles immediately learned on the job.


Understand common set of expectations and a philosophy around management

Build the skills and capabilities to establish and maintain a trusting work environment and relationships within and across departments

Coach and develop others for motivation and performance

Conduct effective improvement discussions and provide the feedback and ongoing support to direct reports

Manage Performance Problems

Conduct Effective Interviewing

Lead High Performance Teams

Resolve conflict

Develop and Retain Talent

Target Audience: Supervisor, Manager, Director


(One day a month)

79

ELLP I: Edwards Lifesciences Leadership Program I

Course ID: ASP10015

The program is created specifically by Edwards’ leaders for Edwards’ leaders. A global, cross-

functional group of participants are invited to come together in California to experience learning

from best-in-class faculty and their programs, customized for Edwards needs. In addition,

participants are given the opportunity to interact directly with Edwards Executive Leadership

Teams (ELT).


Learn how leadership practices affect and support such issues as ethics, communication, feedback and strategy.

Learn the culture-shaping leadership for achieving results, alignment and execution.

Facilitate values-based decision-making and to encourage a common language for communicating these decisions

Bring to life the key concepts of running a business in a competitive environment to create value for the shareholders.

Understand the Edwards financials and business simulation

Participate in Edwards Strategy and convey the information with own team.

Target Audience: Leaders/Senior Leaders (Senior Manager and above)

Location: Irvine Duration: 4.5 days Investment: $0

ELLP II: High Performance Leadership

Course ID: ASP10076

This program has been designed to help Edwards’ senior leaders that will be challenged to

approach their scope of responsibility as if it were their own business. Participants are nominated

by their ELT/SLT leaders. The overall purpose of this program is to synthesize general

management responsibilities while building broad leadership capability.

The objectives for this program are:

Ground participants in strategic and tactical issues associated with developing leadership systems.

Move managers to highly effective by helping leaders develop people development skills.

Execute effective action plans for the design and implementation of a comprehensive leadership strategy.

Define the intended impact of leadership development on strategic business objectives.

Target Audience: Leaders/Senior Leaders (Senior Manager and above)

Pre-requisite: ELLP I: Edwards Lifesciences Leadership Program I.


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Leaders Forum

Course ID: ASP10077

This program has been designed to help proven managers become extraordinary leaders. The

Leaders Forum is targeted at high potential Senior Managers who are preparing for the next

phase of their career.

The program consists of six two-day sessions spread throughout the year. Participants need to

commit to attend all six sessions.


Create a vision as a leader-Life and Career destination- plans of how to get there

Create relationships where both parties are getting more than they are giving

Lead a culture with ethics and code of conduct

Branding yourself toward optimizing our value

Add more discipline to your life, including holding yourself accountable for staying on plan

Target Audience: Senior Managers (high potential)

Location: Irvine Duration: Five sessions Investment: $9,500

(2 ½ -day each session)

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Corporate Business Practices


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Advertising and Promotion Boot Camp

Course ID: LGL10010

This interactive four-hour course is intended for anyone in the US who creates or uses collateral

promoting Edwards or its products. The course also describes some situations creating unique

promotional challenges, and identifies available self-service tools.


Understand all rules and guidance for proper promotional activity, including what it takes to be considered “promotional”

Understand risks and ramifications of improper promotion

Understand compliance issues that can arise in promotional material

Target Audience: US employees who create or use collateral promoting Edwards or its

products

Location: Irvine Duration: 4 hours Investment: $0

Contracts Boot Camp

Course ID: LGL10007

An interactive workshop to enhance your understanding of contract provisions and negotiating

techniques, intended for employees who negotiate or administer contracts on behalf of Edwards.

During this workshop, you will learn about.


Critical contract language and provisions

How to avoid common pitfalls, errors and missteps

Tips for successful negotiations

Special contract issues in the medical device industry

Target Audience: Employees who negotiate or administer contracts on Edwards’ behalf

Location: Various Duration: 30 minutes Investment: $0

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Edwards’ Corporate Culture

Course ID: CORP10005

Our Culture of Integrity: A brief overview of Edwards’ culture of integrity, intended to help

leaders (and future leaders) to connect the dots between Our Credo, our Titanium Book

Standards, and certain Edwards Core Competencies: Integrity and Creative Debate.


Understand specific Titanium Book responsibilities applicable to Edwards leaders

Know that having a corporate culture of integrity is important, and why it is good for business

Be prepared to respond appropriately if an employee Speaks Up about a compliance or ethics concern, including how to recognize and prevent retaliation

Better understand two of the Edwards Core Competencies for which each of us is accountable – Integrity and Creative Debate

Be reminded of Compliance resources that are available to you and your teams

Target Audience: Leaders and those who aspire to be leaders at Edwards


Edwards’ Global Business Practice Standards (“Titanium Book”)

Course ID: LGL10006

A scenario-based review of key elements in the Edwards Global Business Practice Standards,

also referred to as the “Titanium Book,” which serves as Edwards’ code of conduct. This course

is required as part of each employee’s global training plan. Upon completion of this LMS module,

employees should understand key Titanium Book standards, including our obligations to:

Comply with all laws, regulations, industry codes, standards and policies

Conduct our business with honesty and integrity

Support and respect the communities in which we do business

Act in the best interests of Edwards and its stockholders

After completing this training, you will learn:

How to get advice with compliance or ethics concerns

That employees must “Speak Up” if they have an ethics or compliance concern

That Edwards prohibits retaliation for such reports made in good faith

How to recognize and avoid conflicts of interest

Your obligations to protect confidential information and intellectual property

That Edwards supports fair employment practices

Target Audience: All employees (LMS module and instructor led, for manufacturing

employees)

Location: LMS Duration: 45 minutes Investment: $0

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Intellectual Property Boot Camp

Course ID: LGL10003

An interactive workshop for employees new to Edwards, or those early in their careers. The

training will focus on practical IP tools that provide a basic foundation that you can use throughout

your career. After completing this workshop, you will learn:

How to read a patent

How to deal with doctors on IP issues

Brands and how to protect them

How to submit an invention disclosure and patent your inventions

Simple agreements such as confidentiality and consulting agreements

How to spot key IP issues and where to go to resolve them

This fast paced course also includes a group patent exercise, lessons on obtaining patent clearance for new or improved products, confidentiality agreements, branding, trade secrets and copyrights.

Target Audience: Technical, marketing, sales and management level employees

Location: Various Duration: 1 day Investment: $0

Sunshine Law Awareness – Module I Transparency Requirements

Course ID: HCP10001

A brief overview of the Sunshine Law and its impact on employee interactions with customers and

other health care providers. Upon completion of this course, you will be able to:

Describe the requirements of Sunshine Act and the accompanying CMS regulations

Recall which states have transparency and disclosure laws and gain a sound understanding of their parameters

Summarize our approach to capturing payments to Healthcare Professionals

Understand how and when to apply helpful hints listed throughout to your daily responsibilities.

Target Audience: Sales, Marketing, R&D, Clinical, and other functions that interact with, or

arrange payment or travel for, customers and other health care providers

Location: LMS Duration: 30 minutes Investment: $0

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Business Excellence (BEST)


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SIX SIGMA

Six Sigma is a problem solving methodology that uses analytical tools in conjunction with critical thinking to obtain the process and product knowledge that is needed to improve performance

Black Belt

Course ID: QA10021

This program teaches participants the skill-set required to rapidly acquire knowledge so that

better decisions can be made regarding product design and manufacturing processes. It focuses

on the role of critical thinking and correct practical application of analytical techniques to business

critical issues within the organization.


Understand when and why to use a variety of statistical tools that include but are not limited to: regression, hypothesis testing, equivalency testing, DOE, Gage R&R, nested hierarchical studies, robust design and process capability.

Bridge the gap between sound product and process knowledge and practical application of statistical techniques.

Target Audience: Engineers and Scientists primarily focused on product and process

development and improvement

Location: Various Duration: Four weeks Investment: $8,200 (based on 22 attendees)

Champion Training

Course ID: QA10012

This one-day Champion class provides an overview of Lean and Six Sigma methodologies which

are a cornerstone of continuous improvement. The training will enable leaders to champion

projects, drive a culture of critical thinking, fact-based decision making, and continuous

improvement throughout the organization. Most importantly, it will provide guidance on

project/candidate selection and their role in managing the projects.


Understand the training approach that is being used for the Black Belt and Green Belt classes.

Participants will see examples of a small subset of the tools being taught and understand how to identify appropriate projects and select the best candidates.

Target Audience: Directors and above


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Control Charting

Course ID: QA10019

This four hour course focuses on the correct application of control charts to evaluate process and

product behavior. Control charts are traditionally used to "monitor" process performance but they

can also be used as a graphical method to interrogate a process to better understand the major

sources of variation. In addition to showing how these tools can be applied to gain knowledge, the

course will also provide insight into the most common mistakes associated with the interpretation

of these charts.


Determine which control chart should be applied in a given situation.

Gain a working knowledge of the Individual/Moving Range Charts, the X-bar/Range Charts, I/MR/R three-way chart.

Understand the importance of "rational" sub grouping and sampling and how these things impact the usefulness of these charts.



Location: Various Duration: 4 hours Investment: $300 (based on 20 attendees)

Design of Experiments (DOE)

Course ID: QA10400

This two day course is designed to provide an overview of Design of Experiments. DOE is a

powerful analytical tool that is used to evaluate and quantify the impact of multiple input variables

on product or process performance. The course will focus on the execution of full factorial and

fractional factorial designs and how these experiments can be used to gain valuable process and

product insight allowing engineers to make better decisions regarding the management of input

variables. The application of DOE to engineering problems will also be addressed including

topics like Tolerance Development and Robust Design.


Identify and design an experiment that is customized to address their specific issue.

Analyze a DOE with or without the use of statistical software. This will include calculating the effects of input parameters; understanding the difference between statistical significance and practical significance; and the ability to generate graphs which will assist in properly interpreting the results from the DOE.

Use Minitab software to design and evaluate experimental designs.



Location: Various Duration: 2 days Investment: $1,000

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Gage R&R

Course ID: QA10401

This four hour course focuses on the process of evaluating the capability of a measurement

system to meet its intended function. The Gage R&R is a fundamental tool that is used to

quantify the uncertainly associated with a measurement system which includes the device, the

operator, the environment and the product being measured.


Conduct and analyze a Gage R&R for destructive, non-destructive and attribute measurement systems.

Understand the critical differences between the various acceptance standards (e.g. % Study Variation, P to T ratio) that are applied and how these acceptance standards are impacted by things like part selection and study design.



Location: Various Duration: 4 hours Investment: $300

Green Belt

Course ID: QA10022

The Green Belt program teaches a combination of Lean and Six Sigma tools and focuses on the

skills required to be successful executing process improvements in the transactional world. The

DMAIC methodology is used to provide participants a systematic approach, focusing on the role

of critical thinking and correct practical application of analytical techniques to business critical

issues within the organization.


Understand how to apply the Green Belt methodology to your particular project as well as

understand when and why to use the various lean and statistical tools that include but are not

limited to, value steam mapping, nested hierarchical studies, process flow analysis, mistake

proofing and developing standard work.

Target Audience: Personnel who are primarily focused on transactional or administrative

process improvement

Location: Various Duration: 2 weeks Investment: $3,100 (over 2 months)

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NEW PRODUCT DEVELOPMENT (NPD) EXCELLENCE

New Product Development (NPD) Excellence is a program designed to:

Introduce Design for Manufacturability (DFM) principles, tools and techniques upstream to Edwards' NPD Design and Transfer areas

Introduce Lean principles, tools and techniques to improve Edwards' NPD process from concept to launch

NPD Excellence Champion Training

Course ID: QA10402

The NPD Excellence Champion Workshop is intended to provide a high-value, concentrated

overview of the tools and methods that can be implemented to improve Edwards' NPD process.

The focus of the workshop will be on the benefits provided by these improvements, and the

critical role that champions will play in the ultimate success of the initiative.

Upon completion of this course, you will understand how the NPD Excellence techniques can:

Dramatically accelerate the development of high-value new products.

Improve schedule predictability, cost and quality.

Increase quality and efficiency of customer / team / management communication.

Maximize the productivity of finite development resources.

Develop a culture of accountability, innovation, and intolerance of waste.

Target Audience: Product-line managers, Team Leaders, Task Managers, Functional

Managers, Six-Sigma Black Belts / Green Belts, Operations and Engineering Managers, Process

Owners, Design Engineers, and all others with product development management responsibilities


NPD Excellence Design for Manufacturability (DFM) Workshops

Course ID: QA10405

The NPD Excellence DFM Workshops are designed to introduce Design for Manufacturability

principles, tools and techniques to facilitate the identification of project specific opportunities

during the design phase.

After completing this workshop, you will have achieved the following:

An understanding of the Lean Principles and Wastes

Discussed design considerations for product, process, equipment & tooling, line & workstation design

Identified action plans to improve opportunities associated with the design considerations above

Target Audience: Design Engineers & Leaders, NPD Transfer Engineers & Leaders, Mfg

Supervisors, Engineers & Leaders

Location: Various Duration: ½ day each Investment: $0

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NPD Excellence Market Requirements & Risk Mitigation

Course ID: QA10403

The NPD Excellence Marketing Requirements & Risk Mitigation Workshop is designed to

facilitate the following elements for a specific project:

Transfer Voice of the Customer (Market) data into a prioritized list of product design requirements that maximize customer value, market acceptance and profits

Understand the types of risks associated with the project and perform proactive risk identification and mitigation

This workshop will facilitate the creation of the following outputs:

Marketing positioning statement

Top five customer benefits/key differentiators

Prioritized list of features and performance levels

A prioritized risk register

Action assignments to execute the above

Target Audience: Marketing Leaders and Staff, Design Engineers & Leaders, NPD Transfer

Engineers & Leaders

Location: Various Duration: 2 days Investment: $400

NPD Excellence Project Planning & Visual Workflow Management Workshop

Course ID: QA10404

The NPD Excellence Project Planning & Visual Workflow Management Workshop is designed to

generate a realistic project plan including schedule, launch date, budget and resource plan using

collaboration and the Lean Principle of Visual Control for a specific project.

This workshop will facilitate the creation of the following outputs:

Project budget and resource plan

Project milestone schedule

Format for team stand-up meetings

Target Audience: Design Engineers & Leaders, NPD Transfer Engineers & Leaders, Mfg

Supervisors, Engineers & Leaders


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LEAN

A philosophy based on the Toyota Production System that uses a set of principles to maximize customer value and eliminate waste from a given process or system.

5S for the Factory/Workplace

Course ID: QA10415

An overview of the 5S housekeeping technique used to effectively organize work centers in a

factory or workspace to drive quality and jump start a culture change


Understand the different elements of the 5S process

Visualize opportunities using examples from similar environments

Have an understanding of how to utilize each one of the 5S’s to improve your work environment and to ensure that a system in place for long term sustainability

Target Audience: Operators, Directors, Managers, Supervisors, Engineers


Batch vs. Flow Simulation

Course ID: QA10412

An interactive simulation demonstrating the relevance of lean principles and wastes in both

manufacturing and transactional environments

Upon completion of this simulation, you will have:

A practical understanding of how lean principles and wastes can impact processes in different environments

Target Audience: Operators, Directors, Managers, Supervisors, Engineers and other

professionals involved in process improvement


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BEST Lean System (BLS)

Course ID: QA10406

A systematic approach used to reengineer production lines through the integration of people,

materials and machines into a carefully arranged and well designed work unit. A typical project

takes 12 to 16 weeks with a dedicated team of 4 to 6 individuals. The project is executed using a

"Learn, Do" approach. The process is results oriented using a methodology that focuses on Lean

Principles.

After completing the project, you will have achieved the following:

Reengineered a production line incorporating the following elements:

One Piece Flow

Standard Work

Balanced Distribution of Work

Performance Measurement/Visual Controls

Mistake Proofing

Target Audience: Manufacturing and Quality Leaders, Supervisors, Engineers, Planners,

Finance Partners, HR Partners

Location: Project chartered by BU Duration: 16 weeks Investment: $0

BEST pFMEA Mistake Proofing Process

Course ID: QA10413

A systematic approach to mistake proofing that emphasizes the use of engineering controls vs.

procedural controls utilizing existing pFMEAs to identify high severity risks for a given process.


Use a pFMEA to identify high severity items

Categorize risks using the process control hierarchy

Develop action plans to mitigate priority items




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Change Management

Course ID: QA10410

An overview of Change Management focusing on stakeholder identification, communication,

organization impact and training.


Understand the purpose of change management

How to create a stakeholder analysis and communication plan

Implications for organizations and the importance of training




Kaizen

Course ID: QA10417

A training module on how to lead and execute high intensive activities designed to make rapid

improvements quickly and efficiently.


Train a team on the Kaizen process

Execute a planned Kaizen event

Understand the approaches to use during the event

Report results post event



Location: Various Duration: 2 to 5 days Investment: $0

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Kanban

Course ID: QA10418

This training module gives an overview of the Kanban technique and how and when it should be

used to control the flow of production.

Upon completion of this course, you will understand:

The history of Kanban

The different types of Kanban

When and when not to use Kanban

Kanban prerequisites

Target Audience: Plant Managers, Directors of Mfg., Manager, Supervisors, Mfg. Engineers,

Quality Engineers

Location: Various Duration: 1.5 hours Investment: $0

Lean Management System

Course ID: QA10416

The Lean Management System Workshop teaches work center teams how to manage in a lean

environment emphasizing the importance of Process Focus using visual controls, leadership

standard work, and standard accountability for effective management of the shop floor.

Upon completion of this course, you will have:

Identified and create visual controls to improve process health

Developed leadership standard work for management representatives

Applied techniques to drive accountability in the workplace

Target Audience: Plant Managers, Directors of Mfg., Manager, Supervisors, Mfg. Engineers,

Quality Engineers


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Lean Overview for Operators/Professionals

Course ID: QA10407

An overview of the 7 Lean Principles and 8 Wastes that make up one of the elements of the Edwards

Business Excellence SysTem (BEST).


Define and explain Edwards' Business Excellence SysTem (BEST)

Recognize what Lean means at Edwards

Understand what a Lean culture looks like

Identify the 7 Lean Principles and the 8 Wastes

Target Audience: Operators, Directors, Managers, Supervisors, Engineers and other professionals

involved in process improvement


PFEP (Plan for Every Part)

Course ID: QA10419

Explores a method of flowing material efficiently to the point of use, taking into account total cost through

structured inventory reduction, and systematic tailoring of quantity, frequency, and mode of delivery.


Understand the process required to set up and operate PFEP for a given supply area and production line




Process Flow Analysis

Course ID: QA10411

An analysis tool used to follow a product or value object's path through a process using video.

After completing this workshop, you will have:

Identified the essential processing and inspection steps

Systematically identified waste in the process with a view to removing or reducing it.

Quantified the opportunity to reduce the lead time of the process

Calculated value added time as a percent of process throughput time




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Project Charter Training

Course ID: QA10420

The Project Charter Training module is designed to lead a team through the process of creating an

effective problem statement, objective and scope.


Create an effective problem statement

Create a SMART set of objectives

Effectively define the scope of your project




Transactional Process Mapping

Course ID: QA10409

The Transactional Process Mapping Workshop is designed to lead a team through the steps required to

map a specific process including all actions (both value added and non-value added), by identifying inputs

and outputs, rework, roles and responsibilities, pain factors, touch times/elapsed time.

Upon completion of this workshop you will have created the following:

A current state for a specific process

A future state for a specific process

A prioritized list of improvements and an action plan for execution




Value Stream Mapping

Course ID: QA10408

The Value Stream Mapping Workshop is designed to lead a team through the process of mapping

material and information flows for a specific value object including all actions (both value added and non-

value added).

After completing this workshop, you will have created the following:

A current state value stream map for a specific value object

A future state value stream map for a specific value object

A prioritized list of improvements and an action plan for execution




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Employee On-Boarding

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Anatomy and Physiology

Course ID: GHR10020

This course covers a big picture of the anatomy and physiology of the cardiovascular system.


The Anatomy of the heart: The cardiovascular system, location of the heart, heart valves and chambers, heart valve anatomy, blood flow through the heart, explore the heart, components of blood, vasculature and circulation, explore the cardiovascular system, heart physiology, measuring cardiovascular function.

The Heart Physiology- The electrical conduction system that stimulates heart contraction, the phases of the cardiac cycle, and the hemodynamics.

Note: Please be advised to use Internet Explorer 8 or FireFox in order to view this

module.

Target Audience: All New Hires


New Employee Orientation

Course ID: GHR10010

New Employee Orientations occur once a month and will be an all-day session that provides important information on things such as benefits, learning & development, company guidelines and procedure, etc. New employees will be assigned to the next available NEO session after their start date.

Target Audience: All New Hires


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Preventing Workplace Harassment

Course ID: GHR10008

At Edwards Lifesciences, we are committed to providing an environment free from harassment. Managers and anyone who supervises other employees are required to take this two hour class every two years or within 6 months of hire. This program is delivered online through the Edwards Learning Management System (LMS). It is an interactive e-learning course, allowing managers and supervisors to access it from field locations as well as the office, through the Edwards VPN.


Explore and understand situations which tend to result in common mistakes

View eye-opening perspectives on harassment in the workplace and learn what the law and your policies actually say and mean

Distinguish appropriate, casual behavior from inappropriate behavior

Consider “gray areas” and determine the best course of action

Make certain that Supervisors understand their responsibilities and know how to appropriately respond to employee questions and concerns

Target Audience: Manager and anyone who supervises other employees

Location: LMS Duration: 2 hours (US only) Investment: $0

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