April 28 - d284f45nftegze.cloudfront.netd284f45nftegze.cloudfront.net/trackwise/US Agenda.pdf · enable proactive quality management and how mobile solutions are enabling greater

Sparta Connection 2014North American User Conference

San Diego | April 28 - May 1

SPARTAconnection

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Sparta Connection 2014

Please find the event agenda, workshop descriptions and pertinent details for your convenience.

If you require any assistance, please contact an event representative at the Sparta Connection information desk, located in the Atrium, or call:

Alicia Brown1.646.287.6605

Michele Stoddard1.732.496.9863

* Please remember to wear your Sparta Connection badge at all times.

Welcome

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US User Conference | San Diego | April 28 - May 1

Message from the CEO

It is our pleasure to welcome you to San Diego, California for Sparta Connection 2014 – our 11th Annual North American User Conference.

This year we celebrate twenty years of quality management innovation. In that time, the world of quality management has experienced a tremendous amount of change. This change will continue and occur at an ever faster rate as manufacturing operations and regulatory requirements become increasingly more global and complex and as technology innovation changes quality management practices. Today, more than ever, effective quality management is not only a strategic imperative for all manufacturing companies but also a means of competitive differentiation.

We are excited to bring inspired quality management professionals together to share best practices and examine current and future trends. We are pleased to share with you our new innovative quality management solutions and provide a glimpse into future solutions. At this event, you will see first-hand how predictive analytics will enable proactive quality management and how mobile solutions are enabling greater effectiveness and efficiency. Moreover, you will see how our new cloud solution, Stratas, is extending quality management and control into the supply chain.

On behalf of Sparta Systems, I’d like to thank each of you for your loyalty, time and dedication, not only this week, but throughout the year.

Regards,

Eileen MartinsonChief Executive OfficerSparta Systems, Inc.

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Agenda

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Monday, April 28

Pre-Conference Training Lenore

Registration Atrium

Welcome Reception Silver Strand BeachSponsored by Process Stream

9:00 – 5:00

12:00 – 5:00

6:00 – 8:00

Tuesday, April 29

Breakfast Bay Terrace Sponsored by Sprocket Professional Services

Registration Atrium

Kick-off & Welcome Remarks Christian Rockwell, Vice President, Global Marketing, Sparta Systems Commodore C, D & E

CEO Keynote Eileen Martinson, Chief Executive Officer, Sparta Systems Commodore C, D & E

Product & Technology Vision Bruce Kratz, Vice President, Products, Sparta Systems Commodore C, D & E

Break Commodore Foyer Sponsored by TAKE Solutions

Product Roadmap & Showcase Product Management, Sparta Systems Commodore C, D & E

7:30 – 9:00

7:30 – 9:00

9:00 – 9:10

9:10 – 9:30

9:30 – 10:00

10:00 – 10:30

10:30 – 11:00

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Tuesday, April 29

Cloud Technology & Its Implications for Quality Services Jim Attardi, Vice President, Cloud Services, Sparta Systems Commodore C, D & E

Workshop Session 1

Commodore C Commodore A Commodore B

Implementing Stratas: Extending the Quality

System Beyond the Four Walls

The Sparta Technical Advisory Offering

Customer Success Program: What

Macro Level Insights Can I Gain into My

Business?

Lunch Bay Terrace Sponsored by HighPoint Solutions

Workshop Session 2


Advancing TrackWise Analytics: Predictive

Analytics and Unstructured Text

Analysis

Case Study: Planning for Global

Implementation: Configuration Strategies for

Organizing Information within

TrackWise

Upgrade Factory: New Options for

Moving to TrackWise 8.7

11:00 – 11:30

11:45 – 12:45

12:45 – 1:45

1:45 – 2:45

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Tuesday, April 29

Workshop Session 3


Supply Chain Visibility: What Impact Does an

EQMS Have on Your Supply Chain?

Getting the Most Out of Your Sparta

Support

European Regulatory Changes and the

Impact on US Medical Device Manufacturers

Table Topics & Networking BreakCommodore FoyerSponsored by TAKE Solutions

Free Evening

3:00 - 4:00

4:15 – 5:15


Can Open Quality Systems Decrease Compliance Risk? Bob Kenney, Director, Product Strategy, Vault QualityDocs, Veeva Commodore C, D & E

Quality in the High-Tech And Discrete Manufacturing Industry David Brown, Director, Quality Management, Bucher Emhart Glass

Commodore C, D & E


7:30 – 9:00

9:00 – 9:30

9:30 – 10:30

10:30 – 11:00

Wednesday, April 30

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Future Trends in Management System Standards Dr. Nigel Croft, Chairman, TCA Global

Commodore C, D & E

Workshop Session 4


The Future User Experience

Case Study: Leveraging

TrackWise Web Services and Best

Practices in Global Change Control

TrackWise and Vault QualityDocs: Integrating Quality

Processes and Documents

Lunch Bay Terrace Sponsored by HighPoint Solutions

Workshop Session 5


Case Study: Changing the Boundaries on

Conducting Audits with TrackWise AEP, TrackWise Analytics

and Stratas

Discovering Hidden Insights: Advanced

Self-Service Business Intelligence

Case Study: Managing User

Adoption in Your Company

11:00 – 12:00

12:15 - 1:15

1:15 – 2:15

2:15 – 3:15

Wednesday, April 30

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Workshop Session 6


EQMS and Regulatory Intersection: What are

the Keys Unlocking Value and Meeting

Requirements?

Recalls: The Best Recall is the One You

Never Have To Do

Extending Your EQMS into Regulatory

Affairs with Product Registration Tracking


Workshop Session 7


Case Study: TrackWise Analytics Applied in Practice

Case Study: Challenges and

Solutions in Implementing a Single Global

Discrepancy Management System

Accelerating TrackWise

Deployment with Sparta’s Quick

Implementation Packages

Lobby Departure

Evening Farewell EventAir & Space MuseumSponsored by Veeva Systems

3:30 – 4:30

4:30 – 4:45

4:45 – 5:45

6:30

7:00 – 11:00

Wednesday, April 30

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Dangerous DocumentsNancy Singer, Founder, Compliance-Alliance, LLC

Commodore C, D & E


Managing Quality Control in a Complex Manufacturing Environment David Myren, Sr. Program Manager, Applied Materials Commodore C, D & E

Closing Commodore C, D & E

Lunch-To-Go Commodore Foyer Sponsored by HighPoint Solutions

Post-Conference TrainingLenore

Managing Up (Post Conference – Optional)SovereignNancy Singer, Founder, Compliance-Alliance, LLC

7:30 – 9:00

9:00 – 10:30

10:30 – 11:00

11:00 – 11:30

11:30 - 11:45

11:45 -12:30

1:00 – 5:00

1:00 – 5:00

Thursday, May 1

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• Intuitive user experience• Secure access anytime, any device• Self-service reports and dashboards

Visit the Veeva Booth in the Expo and the

Vault QualityDocs Workshop on Wednesday 12:15-1:15 pm

QualityDocs & TrackWise Integration Jointly Developed | Jointly Supported

MADE EASY

Quality Documentation

Really


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Workshops

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Speaker Title CompanyBen Shectman Director, User Experience Sparta Systems

Biswanath Majumdar System Analyst III Perrigo

Bob Kenney Director, Product Strategy, Vault Quality Veeva Systems

Brian Brzezinski Team Lead Sparta Systems

Bruce Kolodziej Analytics Manager Information Builders

Bruce Kratz Vice President, Products Sparta Systems

Christy Nagel Quality Systems Principle Tech Manager Genentech

Craig Regitz Manager, Quality Assurance GlaxoSmithKline

Dave Hartmann Product Manager Sparta Systems

David Brown Director, Quality Management Bucher Emhart Glass

David Myren Sr. Program Manager Applied Materials

James Attardi Vice President, Cloud Services Sparta Systems

Jamie Chumas Program Manager Sparta Systems

Jay Smith Director, Product Management Sparta Systems

Joby George Technical Product Manager Sparta Systems

Joe Goodman Manager, Solutions Consulting Sparta Systems

Joseph Humm Director, Global Sales Operations Sparta Systems

Justin Matthews Global Operations Manager Sparta Systems

Kelly Kuchinski Industry Solution Director Sparta Systems

Kevin Seckel IS Applications Manager Perrigo

KR Karu Industry Solution Director Sparta Systems

Larry Eastman Sr. Quality Advisor Purdue Pharmaceutical

Matthew Kopecky Sr. Solutions Consultant Sparta Systems

Mohan Ponnudurai Industry Solution Director Sparta Systems

Nancy Burrell IT Lead Business Analyst, TrackWise Medtronic

Nancy Singer Founder Compliance-Alliance

Dr. Nigel Croft Chairman TCA Global Alliance

Orlando Banos Project Manager Applied Materials

Paul Marini Global Lead, Center of Excellence Sparta Systems

Dr. Peter Havel Sr VP, MHS Global & Regional Director TUV SUD America Inc.

Rob Richards Sr. Principal IT Project Manager Medtronic

Tami Frederick Global Director, Corp. Quality Systems Perrigo

Tim Waddell Global Quality, Computer Systems Genentech

Tom Rac Global Manager, Technical Advisory Sparta Systems

Speakers

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Tuesday, April 29 | Session 1

Workshop 1 - Commodore CImplementing Stratas: Extending the Quality System Beyond the Four WallsSparta

Listen as we discuss how to extend supplier quality management from a business process perspective. We will also review a guided tutorial on the new innovative Stratas solution.

Workshop 3 - Commodore BCustomer Success Program - What Macro Level Insights Can I Gain into My Business?Sparta

Are you interested in understanding how your quality management solution is being used across the various manufacturing locations, processes and job functions in your business? Would you like to understand how certain quality management process metrics within your business stack up against others in the industry using similar processes? Are you interested using a qualitative executive dashboard to inform your decisions about what tactical and strategic quality infrastructure challenges to tackle next? If you answered “yes” to any or all of the previous questions, Sparta Systems has a free Customer Success Program service for you.

Workshop 2 - Commodore AThe Sparta Technical Advisory OfferingSparta

Hear the elements of what the Technical Advisory Offering is and how it can help your company with scalability, implementation effectiveness and/or whitespace analysis.

T

T

B

B = Business Workshop T = Technical Workshop

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Workshop 1 - Commodore CAdvancing TrackWise Analytics: Predictive Analytics and Unstructured Text AnalysisSparta

Introducing advanced capabilities coming to TrackWise Analytics. Learn how your company can harness existing data to predict the likelihood of an event occurring, such as a device failure or a recall. We will also explore various methods of performing analytics on free text data from TrackWise systems to help determine trends and patterns.

Workshop 3 - Commodore BUpgrade Factory: New Options for Moving to TrackWise 8.7Sparta

Sparta has introduced several new options to upgrade from unsupported versions. Join us as we debunk myths and help bring your users the latest features and user experience.

Workshop 2 - Commodore ACase Study: Planning for Global Implementation: Configuration Strategies for Organizing Information within TrackWiseGlaxoSmithKline & Sparta

Most implementations of new systems start small to demonstrate value. Expansion of these systems to additional areas within a business can prove challenging if the initial system configuration is not scalable. Join us to discuss some strategies for organizing information within TrackWise that allow room to grow. Topics to be covered include: consistency of data between record types; how to support different views of the same information (e.g. by group/dept., by characteristic, by date/time), consistency of information between global group and global record types.

B/T

B

B

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Workshop 1 - Commodore CSupply Chain Visibility: What Impact Does an EQMS Have on Your Supply Chain, and Why is it Important?Sparta

Listen as we outline how quality problems or inefficiencies along the supply chain can cost companies money and impact revenue. We will review how an EQMS can address these supply chain issues, which includes better management/correction of problems with an organization’s value delivery chain, better visibility into the supply chain, challenges to prevent problems from happening and better supplier quality management.

Workshop 3 - Commodore BEuropean Regulatory Changes and the Impact on U.S. Medical Device ManufacturersTUV & Sparta

European medical device regulations are changing and the impact on the U.S. Medical Device manufacturers is significant. Learn the consequences of the EC recommendations in the areas of audits and new scrutiny on clinical data and software controlled medical devices with respect to patient safety. Learn how to demystify these new requirements and tips on how Medical Device manufacturers can succeed in the European market.

Workshop 2 - Commodore AGetting the Most Out of Your Sparta SupportSparta

Review the levels of TrackWise support that are available to you, the user community, and discuss best practices for leveraging this critical offering.

B

B

T


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Wednesday, April 30 | Session 4

Workshop 3 - Commodore BTrackWise and Vault QualityDocs: Integrating Quality Processes and DocumentsVeeva & Sparta

Sparta Systems and Veeva Systems, Sparta’s preferred partner for enterprise content management, will discuss the vision for a jointly supported integration between TrackWise and Veeva’s Vault QualityDocs. We will explore the Vault QualityDocs solution and how the integration will work to provide value to customers in the area of change management.

Workshop 2 - Commodore ACase Study: Leveraging TrackWise Web Services and Best Practices in Global Change ControlPerrigo & Sparta

This technical workshop will review how Perrigo has leveraged TrackWise Web Services to integrate their global change control process with a variety of other systems. They will demonstrate how web services helped provide a closed-loop process to contribute key assessment information such as products, licenses, sites of manufacture and more.

B/T

T


Workshop 1 - Commodore CThe Future User ExperienceSparta

Join our Director of User Experience as he shares the conceptual design vision for the future-state user experience of TrackWise.

B

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Workshop 1 - Commodore CCase Study: Changing the Boundaries on Conducting Audits with TrackWise AEP, TrackWise Analytics and StratasPurdue Pharma & Sparta

Conducting service provider and supplier audits offers a critical view of their systems and compliance with operational and business procedures. Observations and findings from these audits can be used to build a foundation for risk management and help align audit resources and manage compliance risks. Hear how Purdue Pharma effectively consolidated the data collection from various disconnected systems for audits, observations, and CAPAs into their TrackWise EQMS. Using the web services connectivity with the current ERP system, Purdue was able to streamline the reporting process and automate their Approved Source List (ASL). Purdue will also discuss their future plans to incorporate the use of TrackWise Analytics and the newly launched Stratas product to enhance the supplier commitments, scorecarding, approvals, dashboard and reporting.

Workshop 3 - Commodore BCase Study: Managing User Adoption in Your CompanyMedtronic & Sparta

Obtaining organizational readiness, user adoption and change management are key elements for any efficient software roll out. Hear Medtronic describe the tools your company will need in place to support TrackWise users to drive user adoption, proficiency and productivity.

Workshop 2 - Commodore ADiscovering Hidden Insights: Advanced Self-Service Business IntelligenceSparta

This interactive workshop will demonstrate some of the types of advanced reports and charts that can be created with TrackWise Analytics. We will also take a sneak peek at some new types of innovative reports and visualizations coming soon to TrackWise Analytics, including map charts, cluster analysis, matrix charts, treemaps, slider charts and more.

B/T

B

T


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Workshop 3 - Commodore BExtending Your EQMS into Regulatory Affairs with Product Registration TrackingSparta

Managing product registrations with dozens of regulatory agencies, each with their own requirements, can be a challenge. Join us as we demonstrate how the TrackWise solution enables companies to track the full lifecycle of the product registration process so they can bring product to market with greater speed and efficiency while maintaining compliance with global regulatory bodies.

Workshop 1 - Commodore CEQMS and Regulatory Intersection: What are the Keys Unlocking Values and Meeting Requirements?Sparta

Regulations are changing and evolving at the same time the cost and margin pressures are increasing in all industries. The connection between quality and compliance has never been more critical. Learn how TrackWise addresses regulatory reporting challenges and delivers regulatory reporting solutions to meet key needs such as eMDR, eMDV, UDI.

Workshop 2 - Commodore ARecalls: The Best Recall is the One You Never Have To DoSparta

In an effort to reduce costs, Brand Owners are outsourcing most of the manufacturing and packaging and relying on more global suppliers to reduce costs and stay competitive. But the complexity of this global vendor network provides little to no visibility into the procedures and processes used in developing finished goods. This increases the risk to the brand owner, the brand itself, and most importantly the consumer. Attend this session to discuss the levels of risk and the associated potential accelerating issue resolution costs. Learn where issues happen, how they can impact the company, and how EQMS can help companies reduce that risk through automated quality processes and real-time updates from outside vendors.

B

B

B

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Workshop 1 - Commodore CCase Study: TrackWise Analytics Applied in PracticePar Pharma & Sparta

Join us for an overview and demonstration of TrackWise Analytics, Sparta’s advanced ad-hoc reporting and analytics solution. We will then take a look at a real example of how TrackWise Analytics is being leveraged to drive business outcomes at Par Pharmaceutical. The discussion will include building the business justification, current usage and future plans, validation approach and the value TrackWise Analytics has brought to the organization.

Workshop 3 - Commodore BAccelerating TrackWise Deployment with Sparta’s Quick Implementation PackagesSparta

Our solutions delivery methodology is designed to deliver holistic, enterprise quality management solutions based on aggressive timelines. Combining industry-standard system development lifecycle (SDLC) practices with rapid application prototyping (RAP) enables us to deliver solutions tailored to your company’s unique quality, compliance and regulatory needs. Listen as we discuss Sparta’s QIPs (Quick Implementation Packages) and how they can help accelerate deployment of key functionality for companies wishing to leverage our best practices approach.

Workshop 2 - Commodore ACase Study: Challenges and Solutions in Implementing a Single Global Discrepancy Management SystemGenentech & Sparta

Hear Genentech describe the challenges and solutions in implementing a single global discrepancy management system across 25 sites/functions that is simple to use with flexibility to accommodate local and legal requirements in addition to multiple manufacturing technologies.

B

B

B


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Access the Sparta ExpertsDuring all breaks, please visit the exhibition area to meet members of Sparta Systems Product Management, Education, Support and Services teams.

Meet with the team and schedule one-on-one sessions. Access to our subject matter experts will provide insight on how to leverage and scale your TrackWise investment, how to maximize Sparta Systems’ support and services and learn about new training offerings.

Help Us Help YouSign up for a 30 minute usability study on Stratas, TrackWise Audit Execution Package or TrackWise Mobile. Register now at the Product Management table to use the new products in a hands-on environment.

Sponsors


Sponsors

Diamond Sponsor

Quality Documentation

MADE EASY

• More efficient review cycles• Direct, secure access for partners• Insights into content status

Powerful, cloud-based quality document management together with your Sparta QMS

Visit the Veeva Booth in the Expo and the

Vault QualityDocs Workshop on Wednesday 12:15-1:15 pm

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Platinum Sponsor

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Platinum Sponsor Gold Sponsor

YOUR ONE-STOP SOURCE FOR ALL SYSTEMS THAT SUPPORT THE QUALITY FRAMEWORK

MOST EXPERIENCED SPARTA SYSTEMS PARTNER

Silver Sponsor

Breakfast Sponsor

TAKE Life Sciences are domain experts, driven by contributing to the success of our clients. We provide consulting, technology and business process services to Life Sciences clients across domains such as Quality, Clinical, Regulatory, and Safety.

We deliver total support through the application of our industry insight and domain expertise to develop and implement the right solution for your business.

/TAKESolutions

/company/[email protected]

takesolutions.com/lifesciences

Improving Outcomes in Life Sciences

Headquarters - Princeton, NJ502 Carnegie Center, Suite 100

+1 609 720 1002

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Silver Sponsor

Sparta Systems would like to thank our sponsors!

Platinum Sponsor

Gold Sponsor Silver Sponsor

Breakfast Sponsor Tabletop Sponsor

Tabletop SponsorTabletop Sponsor

Diamond Sponsor

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Notes

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Notes

Corporate OfficeSparta Systems, Inc.2000 Waterview Drive, Suite 300Hamilton, NJ 08691(888) 261-5948(609) 807-5100 [email protected]

Europe OfficeSparta Systems Europe, Ltd.1 Hachoshlim St.Herzliya, Israel 46724+972 9 970 [email protected]

Asia Pacific OfficeSparta Systems, Inc.31, Rochester Drive, Level 24 Singapore 138637 +65 [email protected]

Europe Sales OfficesUnited KingdomPortland House, Stag PlaceLondon SW1E 5RS, UKPhone: +44 (0) 20 7869 8012

BerlinPotsdamer Platz 10Haus 2 / 5. OG 10785 BerlinTelefon: +49 (030) 300 11 48 -14Fax: + 49 (030) 300 11 45 -20

Austria, ViennaTelefon: +43 (1 22) 787 190All other European Regions:+972-9-970-6000 Option 1

www.spartasystems.com