4th Ann ual Data Integrity Validation - cbinet.com · 10:30 “Homo Sapiens atque Integritas Notitia” (Human Beings and Data Integrity) You might have noticed that modern pharmaceutical

REGISTER AT WWW.CBINET.COM/DATAINTEGRITY • 800-817-8601

A division ofUBM Americas

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Bryan Blank, Principal & Chief Information Officer, Sharp Point Security Solutions, LLC

Steven Brown, BSE, MBA, CSSBB, Senior Manager, Systems and Technology Management, Celgene Corporation

Felicia Ford-Rice, Director, PAREXEL International

Calvin Kim, Senior GXP IT Auditor, Bayer

Heather Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation

Orlando López, E-Compliance and E-Records Integrity, SME

Ryan Ott, Managing Partner, Azzur Group, LLC

Matthew Paquette, Product Specialist, Charles River

Chinmoy Roy, Senior Systems Application Engineer, Genentech (retired), Independent Consultant

J Loren Smith, Senior Manager, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical, Inc.

Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care

Teri Stokes, Director, Quality Assurance Compliance, Cytel

Robert Wherry, MSc MS CPGP CQA CPIP, Head, R&D Data Systems, Quality Assurance and Compliance, Shire plc

Chris Wubbolt, Principal Consultant, QACV Consulting, LLC

INDUSTRY’S LEADING SUBJECT MATTER EXPERTS:

Data Integrity Validation

AUGUST 15-16, 2018 • COURTYARD BOSTON CAMBRIDGE • BOSTON, MA

Overcome Roadblocks, Identify Solutions and Implement Processes for a Successful Data Governance Program

4th Annual

TOP THREE REASONS TO ATTEND

1 Gain an In-Depth Analysis of MHRA’s Final Guidance on GXP Data Integrity

2 Learn How to Build a Culture of Data Integrity Through a Comprehensive Data Governance Program

3 Education Across GXP — Detect Data Integrity Lapses in the Laboratory, Manufacturing and Clinical Environments

Choose Between Two Customized Workshops Based on Experience Level:

INTERMEDIATE: Implement a Data Governance Plan that Suits Your Organization’s Processes

ADVANCED: Utilize the GAMP Data Integrity Maturity Model to Assess Your Effectiveness


Premier Media Partners: Supporting Media Partners:

DAY ONE WEDNESDAY, AUGUST 15, 20187:30 Conference Check-In and Continental Breakfast

8:15 Conference Chairman’s Welcome and Opening Remarks

8:30 Data Integrity Around the World — Evaluate the Trends from Global Regulatory Standards

9:15 Analyze MHRA’s New GXP Data Integrity Guidance

10:00 Networking and Refreshment Break and Office Hours

10:30 “Homo Sapiens atque Integritas Notitia” (Human Beings and Data Integrity)

11:15 Pilot Implementation — How Moving to a Paperless Solution Achieves Process Improvements

12:00 Networking Luncheon

1:00 Eliminate Risk and Human Error in Manufacturing and Laboratory Processes

1:45 CHOOSE BETWEEN TWO IN-CONFERENCE WORKSHOPS (A-B)

Workshop B ADVANCED Utilize the GAMP Data Integrity Maturity Model to Assess Your Effectiveness

Workshop A INTERMEDIATE Implement a Data Governance Plan that Suits Your Organization’s Processes

*There will be a 30-minute networking and refreshment break at 3:15pm

5:15 Close of Day One | Networking Reception hosted by:

ALIDATION WEEK24TH ANNUAL

&

DAY TWO THURSDAY, AUGUST 16, 20187:30 Continental Breakfast and Office Hours

8:00 Conference Chairman’s Review of Day One

8:15 Innovations in the Cloud — Simplifying the Quality Systems Validation Process

9:00 Implement Cyber Security Best Practices to Support IT Data Governance Programs


10:15 CHOOSE FROM TWO 90-MINUTE SESSIONS (1-2)

Session 2 GCP FOCUS Navigate Data Integrity Expectations in the GCP Environment

Session 1 GMP FOCUS Interpret FDA and MHRA Guidelines from a Manufacturing Mindset


12:45 CHOOSE FROM TWO 90-MINUTE SESSIONS (3-4)

Session 4 GMP FOCUS Apply Data Governance to Manufacturing Systems and Process Automation

Session 3 GMP & GCP FOCUSIt’s Elementary! Detecting Data Integrity Lapses in the Laboratory, Manufacturing and Clinical Environments


2:45 INSPECTION READINESS CRASH COURSE How Not to Crash and Burn During Your Next Agency Inspection

4:15 PANEL DISCUSSION Ask the Experts — Open Audience Q&A to Discuss Core Data Integrity Concepts and Challenges

5:00 Chairman’s Closing Remarks and Close of Conference

Foyer

Ballroom A

Ballroom B

Ballroom A

Ballroom A

Ballroom A Riverview

Bistro

Ballroom B

Ballroom B

Ballroom A



Ballroom B

Ballroom A

Bistro


DAY ONE WEDNESDAY, AUGUST 15, 20187:30 Conference Check-In and Continental Breakfast

8:15 Conference Chairman’s Welcome and Opening Remarks Robert Wherry, MSc MS CPGP CQA CPIP, Head, R&D Data Systems, Quality Assurance and Compliance, Shire plc

8:30 Data Integrity Around the World — Evaluate the Trends from Global Regulatory StandardsWith eight health agency data integrity-related published guidance documents, this session provides a practical look at the correlation, evaluation and trends between them. This session focuses on electronic records integrity. • Key elements of each guidance document• Consistencies between guidance documents• Differences between guidance documents• Trends between guidance documentsOrlando López, E-Compliance and E-Records Integrity, SME

9:15 Analyze MHRA’s New GXP Data Integrity Guidance The MHRA have led the way for clarifying guidance in the area of data integrity, first addressing the needs of GMP/GDP regulated data and now harmonizing the language to apply easily to GLP and GCP arenas. The UK agency has also worked closely with the PIC/s organization in recent years, so we expect to see traces of the MHRA guidance document in the upcoming PIC/s revision. In this session, attendees hear about the updated language and new sections of the industry-reviewed guidance and have an opportunity to share their views of its success.• New definitions for data collection, data processing,

data transfer and data migration as well as detailed examination of the creation of “true copies”

• Promotion of a risk-based data review approach, including the use of exception-focused review of data, audit trails and the role of periodic data review

• Clarification of data backup and practical approaches to data archive

• Understand the roles and responsibilities of IT suppliers, especially cloud hosting service providers

Heather Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation

Office Hours — Meet one-on-one with speakers to solve your individual data integrity challenges

10:00 Networking & Refreshment Break

10:30 “Homo Sapiens atque Integritas Notitia” (Human Beings and Data Integrity)You might have noticed that modern pharmaceutical and medical device companies are infested with human beings. Brit Marling says that, “[h]uman beings are flawed and complicated and messy.” In this session, we start a discussion on the various aspects (and academic disciplines) of human behavior that can and do impact data integrity within your organization, through the combined lenses of psycho-/socio-/anthropo-logy and economics. We also discuss how you can use a rudimentary understanding of these disciplines to

increase the inherent integrity of your organization and the data it generates.• Detection

* how to recognize fraud and human error, and how to tell the difference

* how to understand more of what your data is trying to tell you

• Prevention* thinking about how people are really incentivized

and managed in your organization, and the potential resultant behaviors

* the power of belief, humility and norms to increase data integrity

* concepts of organizational maturity as they apply to data integrity

J Loren Smith, Senior Manager, Global Compliance & Ethics, Computer Systems/Data Integrity, BioMarin Pharmaceutical, Inc.

11:15 Pilot Implementation – How Moving to a Paperless Solution Achieves Process ImprovementsThis session provides a practical look at the implementation of a ValGenesis system and how it improves processes.• Gain real-time visibility• Understand data integrity benefits• Improve good documentation practices• Achieve 100% paperless validation lifecycle process• Prepare for audit readinessLizzandra Rivera, Associate Director, IT Quality, Alexion PharmaceuticalsSteve Thompson, Senior Manager, Professional Services, ValGenesis, Inc.


1:00 Eliminate Risk and Human Error in Manufacturing and Laboratory Processes The human element can never be completely eliminated, but it’s important to understand what can be done to mitigate the risk for human error and how it relates to data integrity. There are two main pillars that link data integrity compliance to our industry: 1) software and electronic data compliance and 2) risk mitigation strategies for human error. Reducing the risk for human error in our manufacturing and laboratory processes ensure that we comply with data integrity laws and regulations while building quality into everyday processes and thus keeping patients and drugs safe. As laboratory testing shifts from observation-based qualitative methods to more objective quantitative methods, a focus on data integrity becomes more critical to ensure overall product quality and patient safety. • Utilize an organized, risk-based approach to

close human error gaps in processes to prove to all stakeholders that the data used to determine product quality is integral and accurate

• Examine real-world examples from the industry to allow for the evaluation of processes for unnecessary data integrity and human error risks

• Reduce a laboratory’s risk to human error and data integrity violations in the future through implementing automation

Matthew Paquette, Product Specialist, Charles River


1:45 C H O O S E B E T W E E N T W O I N - C O N F E R E N C E W O R K S H O P S (A - B )

INTERMEDIATE Implement a Data Governance Plan that Suits

Your Organization’s Processes

ADVANCED Utilize the GAMP Data Integrity Maturity Model

to Assess Your Effectiveness I. Overview of the GAMP

Guide on Electronic Records and Data Integrity• Review key points of the guide,

including:* governance* data lifecycle* risk management* data integrity programs

II. Review the Data Integrity Maturity Model• Understand the guidelines

provided by the model • Learn to apply the model to your

data governance program

III. Conducting the Self-Assessment • Preparation• Roles and responsibilities• Mitigation• Follow-up

IV. Interactive Exercise Attendees break into teams to develop a plan for conducting data integrity self-assessments against the GAMP data integrity maturity model.

BONUS MATERIAL • A consolidated plan, developed

by the various teams, is collated and provided to attendees

Chris Wubbolt, Principal Consultant, QACV Consulting, LLC

Calvin Kim, Senior GXP IT Auditor, Bayer

B

A

I. Understand Regulatory Requirements for Data Integrity (DI)• What is DI and what are its

principles?• Find out why data integrity is not a

new regulatory requirement• Compendial 21 CFR Part 11

requirements• Learn why Part 11 requirements

are not the same as data integrity requirements

II. Explore Data Integrity Guidances from Different Regulatory Agencies• Review data integrity guidances

from regulatory agencies, including FDA, MHRA and WHO

• Understand the distinctions and similarities between the DI guidances

• Learn which DI guidances are meant for legacy systems

III. Learn How to Use “The Least Burdensome Approach” to Develop Your DI Plan • Understand the “Least

Burdensome Approach” and the benefits of its use to develop a DI plan

• Discover regulations that support the “Least Burdensome Approach”

• Examine Warning Letter trends that support a “Least Burdensome Approach” for a DI plan

• Learn how to use the DI guidances to validate your DI plan

• Summarize the steps to develop your DI plan

IV. Develop a Data Integrity Management System • Analyze deviant human behaviors

and the data manipulation triangle• Gain familiarity with the data

integrity controls triad

• Understand the essentials of the 5-p model of data integrity

• Learn how to use the 5-p model to bullet proof your data integrity audits by regulators

V. Interactive Exercise Attendees should bring a list of general data integrity implementation challenges that they are encountering in their respective companies. The workshop opens with participants breaking up into smaller work groups to discuss the challenges. The workshop concludes with participants breaking up into their original groups to apply the lessons learned from the workshop to develop a DI plan that they take back to work.

BONUS MATERIAL • A template SOP for “Performing

An Audit Trail Review”

Chinmoy Roy, Senior Systems Application Engineer, Genentech (retired), Independent Consultant

5:15 Close of Day One

NETWORKING RECEPTION HOSTED BY:

ALIDATION WEEK24TH ANNUAL

OCTOBER 22-24, 2018 • CORONADO ISLAND MARRIOTT • SAN DIEGO, CA

immediately following the final session on day one

There will be a networking and refreshment break at 3:15pm

I. What Is Data Integrity? • ALCOA+• The data lifecycle• What auditors are seeing — Real-life examples

II. FDA Regulations and Guidances• 21 CFR Part 11 (1997)• Data Integrity Compliance with cGMP for Industry (2016)• Part 11, Electronic Records; Electronic Signatures —

Scope and Application (2003)

III. MHRA• Guidance on GXP Data Integrity (2018)

IV. Regulations and Guidance Related to Data Integrity for Computerized Systems• European Commission Annex 11 — Computerised

Systems (2011)

V. From Paper to Electronic• Ensuring data integrity during data migration activities

VI. How Do We Ensure the Integrity of Our Electronic Data in Validated Computerized Systems?• Dynamic vs. static data• User access control• Role-based security• Physical security• Backup, restore and disaster recovery• Data retention• Date and time stamps• Printouts vs. electronic copies• Audit trails• Electronic signaturesRaul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care


10:15 CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (1-2)

GMP FOCUS Interpret FDA and MHRA Guidelines From a Manufacturing Mindset1

DAY TWO THURSDAY, AUGUST 16, 2018


7:30 Continental Breakfast

8:00 Conference Chairman’s Review of Day OneRobert Wherry, MSc MS CPGP CQA CPIP, Head, R&D Data Systems, Quality Assurance and Compliance, Shire plc

8:15 Innovations in the Cloud — Simplifying the Quality Systems Validation ProcessLife science companies operating under GxP regulations must perform validation in order to be compliant. They must demonstrate that their manufacturing processes will produce products that ensure regulatory compliance with cGMP principles, and make certain products deliver the expected results and do not harm the consumer. This session discusses:• Adhering to FDA requirements• QMS approach to validation• Elements of a risk-based validation plan• Possible challenges and risks• Future of cloud validation

Bruce Kratz, Chief Technology Officer, Sparta Systems

9:00 Implement Cyber Security Best Practices to Support IT Data Governance ProgramsWith cyber security becoming a growing concern across many industries, the life sciences industry must be prepared for securing electronic and cloud-based data. This session presents an overview of potential cyber threats, strategies life sciences companies can employ to prepare for cyber breaches and analyzes examples of cyber qualification and validation best practices.• Consider cyber security issues in validation processes• Determine how cyber qualification can be integrated

into a data governance program• Implement personnel training for cyber safety• Understand the potential cyber risks and data

integrity lapses that can occur with inadequate cyber qualification

BONUS MATERIAL• Example checklist for cyber security

best practices

Bryan Blank, Principal & Chief Information Officer, Sharp Point Security Solutions, LLC

Ryan Ott, Managing Partner, Azzur Group, LLC



I. Overview of the GCP Data Integrity Requirements • Application of data integrity principles to GCP• Review applicable regulatory guidance

II. e-Clinical Systems and Examples• Review different types of e-Clinical systems• Analyze examples of issues that may occur

III. Conduct GCP Data Integrity Assessments• Establish a process to conduct GCP data

integrity assessments• Review examplesChris Wubbolt, Principal Consultant, QACV Consulting, LLC

GCP FOCUS Navigate Data Integrity Expectations in the GCP Environment 2

11:45 NETWORKING LUNCHEON


Data integrity, while not a new regulatory requirement, has been a hot topic for the past several years and is highly publicized in numerous regulatory authority inspections conducted in multiple countries. Initially, data integrity lapses seemed to be focused on pharmaceutical laboratories, subject to good manufacturing practices. However, data integrity lapses have also manifested in manufacturing operations as well as in clinical environments.

I. You Keep Using That Word, I Do Not Think It Means What You Think It Means! • Explore data integrity concepts

II. New Rules• Current guidance documents from regulatory

authorities and non-governmental entities

III. Can You See What I See? • A brief review of GXP regulatory authority inspection

observations both old and new

IV. Which One of These Things Is Not Like the Other? • A summary of case studies that compares and

contrasts how data integrity lapses occur across laboratory, manufacturing and clinical environments

V. Let’s Play! Interactive ExerciseParticipants assess GMP laboratory, manufacturing operations and clinical environment data integrity lapses through a game of DI Jeopardy.

BONUS MATERIAL• Tabulation of current data integrity guidelines

by GXP content, data integrity assessment template for GMP laboratory, manufacturing environment and clinical environment

Felicia Ford-Rice, Director, PAREXEL International

12:45 CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (3-4)

GMP & GCP FOCUSIt’s Elementary! Detecting Data Integrity Lapses in the Laboratory,

Manufacturing and Clinical Environments3

I. Manufacturing Technology Overview• Understand technology layers and system architecture• Define the major features of process automation and

manufacturing systems

II. Components of Data Governance• Regulations, guidelines and the QMS• Technology controls• Organizational culture

III. Assess Legacy Systems• Organize the effort• Develop assessment boundaries• Establish an assessment methodology• Execution, gap identification and remediation• Information management• Incorporation into routine operations

IV. Interactive Exercise — Assess Legacy SystemsParticipants break up into several teams and discuss the sort of systems they work with. Select an example system and develop a brief sketch of the system

architecture to share with the rest of the class. Then, create a high process map to illustrate how the system is used within the business process. Translate this information to a data map to show the data lifecycle and perform a cursory data integrity assessment. Finally, identify schemes of remediating gaps, managing assessment information and incorporating system governance requirements into routine operations.

V. Building Data Integrity Into Systems• Perform early lifecycle assessments• Validation practices• System management practices

BONUS MATERIAL • System assessment examples and templates

Steven Brown, BSE, MBA, CSSBB, Senior Manager, Systems and Technology Management, Celgene Corporation

GMP FOCUS Apply Data Governance to Manufacturing Systems

and Process Automation 4




A GREAT PLACE TO MEET YOUR MARKETTake advantage of the best opportunity to meet potential clients face-to-face. Build relationships

while demonstrating thought leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact Hunter Gates at 339-298-2108 or [email protected].

CONFERENCE SPONSORS INCLUDE:

5:00 CHAIRMAN’S CLOSING REMARKS AND CLOSE OF CONFERENCE

2:45 INSPECTION READINESS CRASH COURSE How Not to Crash and Burn During Your Next Agency Inspection

I Walking a Mile in the Shoes of the Agency Auditor• Responsibilities of the agencies• Agency assumptions — The paradigm• Transparency — What it sometimes appears to be and what it is not• What would an auditor like to do and see?• Characteristics of a trustworthy auditee

II. You Still Haven’t Found What They’re Looking For…• Roles and responsibilities during inspections• Reverse engineering preparedness• Agency requests — Anticipation, interpretation and clarification• Sorry seems to be the hardest word — Admission of known pre-audit errors

III. Inspectional Observations and Responses• Mama Mia Culpa — Admission of audit-discovered errors and clarifying misperceptions• Band-Aids, therapy or surgery — Are you fixing the problem or not?

IV. Interactive ExerciseWorking through some potential data integrity issues, discuss how to prepare for those issues from an inspection readiness perspective.

BONUS MATERIAL• Data Integrity Risk Assessment (DIRA) template• Periodic Review Template

Robert Wherry, MSc MS CPGP CQA CPIP, Head, R&D Data Systems, Quality Assurance and Compliance, Shire plc

4:15 PANEL DISCUSSION Ask the Experts — Open Audience Q&A to Discuss Core Data Integrity Concepts and Challenges In this audience-driven Q&A session, a panel of industry experts gather to respond to live questions from the audience and share strategies that have proven successful.• Learn from experts on top challenges regarding data integrity • Engage in dynamic dialogue to discuss expected regulatory actions• Hear lessons learned and best practices for managing a positive data integrity program• Understand the relationship between data privacy, data integrity and data accuracy MODERATOR: Robert Wherry, MSc MS CPGP CQA CPIP, Head, R&D Data Systems, Quality Assurance and Compliance, Shire plc PANELISTS: Steven Brown, BSE, MBA, CSSBB, Senior Manager, Systems and Technology Management, Celgene Corporation Felicia Ford-Rice, RAC, Director, Compliance and Regulatory Strategy, PAREXEL InternationalTeri Stokes, Director, Quality Assurance Compliance, Cytel Chinmoy Roy, Senior Systems Application Engineer, Genentech (retired), Independent Consultant Chris Wubbolt, Principal Consultant, QACV Consulting, LLC

Paperless Validation Software Solutions

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Book Now! The Courtyard Boston Cambridge is accepting reservations on a space and rate availability basis. Rooms are limited, so please book early. All travel arrangements subject to availability.

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REGISTRATION FEE: ADVANTAGE PRICING Standard Onsite Conference $2099 $2399 $2499

Register by June 8, 2018 and SAVE $300. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.) PLEASE NOTE: All advertised discounts are taken from the full, Standard Rate.

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SUBSTITUTION AND CANCELLATION: Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. Cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $399 administrative charge. No refunds will be made after this date; however, the registration fee less the $399 administrative charge can be credited to another CBI conference if you register within 30 days from the date of this conference to an alternative CBI conference scheduled within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the conference registration fee only. CBI reserves the right to alter this program without prior notice. Please Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made without notice. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or CBI.

CHOOSE BREAKOUT SESS IONS BELOW

Wednesday, August 15, 20181:30 - 5:00 A B

Thursday, August 16, 201810:15 - 11:45 1 2

12:45 - 2:15 3 4

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Data Integrity Validation

AUGUST 15-16, 2018 • COURTYARD BOSTON CAMBRIDGE • BOSTON, MA

Overcome Roadblocks, Identify Solutions and Implement Processes for a Successful Data Governance Program

4th Annual

A division ofUBM Americas

R E G I S T E R BY J U N E 8 , 2 0 1 8 A N D S AV E $ 3 0 0 !

ANY QUESTIONS OR TO REGISTER CONTACT:

Michael Berube phone 339-298-2185

email [email protected]

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4th Ann ual Data Integrity Validation - cbinet.com · 10:30 “Homo Sapiens atque Integritas Notitia” (Human Beings and Data Integrity) You might have noticed that modern pharmaceutical