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IPA'S DATA INTEGRITY CONFERENCE
October 18-19, 2017
Preliminary Conference Agenda & Contents:
  • 8:15 AM – 8:55 AM
  • Registration, Networking and Continental Breakfast

  • 8:55 AM – 9:00 AM
  • Chair’s Welcome Note
    Natasha Demberg, BSc, MSc, Vice President of Pharmaceutical Solutions, Neopharm Labs

  • 9:00 AM – 9:45 AM
  • History of Data Integrity

    James P. Stumpff, RPh, Principal Consultant, PAREXEL International, Former FDA

    • Suggested Reading

    • Industry Regulation

    • Historical Events

    • Regulatory Changes

    • Current Trends


  • 9:45 AM – 10:45 AM
  • Data Integrity – Regulatory Expectations, Observations and Trends

    Oleg Trigub, Director, Global IT Quality, Covance

    Data integrity is not a new requirement within the regulated healthcare industry; however regulatory agency guidances and regulations recently provided additional clarification for computer system controls. This presentations will explore the following topics related to data integrity.

    • Types of regulatory observations

    • Regulatory Inspection Focus

    • What is Data Integrity?

    • How important is Data Integrity?

    • Data integrity Clarifications (watch out for pitfalls!)

    • Data Integrity Observation Categories

    • Data Integrity Trends

    • Industry Implications

    • Additional Points of Interest


  • 10:45 AM – 11:00 AM
  • Mid-morning Refreshment Break

  • 11:00 AM – 11:45 AM
  • Understanding the Data Integrity Guidance and the link to ALCOA

    Geoffrey Grove, Ph.D, Product Manager and Application Scientist, Sotax

    • Current Global Data Integrity Guidance (FDA, Health Canada, MHRA and WHO)

    • Understanding ALCOA with Case Studies:

      • What makes it Attributable?

      • What makes it “Legible”?

      • What are the requirements for “Contemporaneously Recorded”?

      • What are the requirements for “Original or True Copy”?

      • What are the requirements for “Accurate”?


  • 11:45 AM – 12:00 PM
  • Panel Q & A
    James P. Stumpff, RPh, Principal Consultant, PAREXEL International, Former FDA
    Oleg Trigub, Director, Global IT Quality, Covance
    Geoffrey Grove, Ph.D, Product Manager and Application Scientist, Sotax

  • 12:00 PM – 1:00 PM/span>
  • Networking Lunch

  • 1:00 PM – 2:00 PM
  • ALCOA is GxP

    Chris Wubbolt, Principal Consultant, QACV Consulting

    • Overview of ALCOA Principles

      • Review each of the ALCOA principles and considerations for data integrity

      • Provide both paper and electronic examples of each ALCOA principle

      • Discuss examples of data integrity issues for each ALCOA principle

    • Discussion of “Accurate” part of ALCOA

      • Focus on what the term “Accurate” really means in relation to GxP

      • Provide examples from regulatory guidance

    • Review how “Accurate” expands into GxP

      • Provide specific GxP examples of “Accurate” in the context of data integrity


  • 2:00 PM – 3:00 PM
  • Build a Toolbox for Successful Data Integrity Implementation from the Corporate to the Site-wide Network

    Chris Binion, Manager, Global Quality , Corporate, Data Integrity Compliance, Officer, Patheon

    • Introduction

    • Going Deep-Preparing the Right Plan

      • Developing a Strategic and Effective the Plan

      • Understanding Capabilities and the Universe of Risk

      • Understanding Motivators for Behavior

      • Activity

    • Going Long-Sustainable Programs

      • Defining Expectations

      • Self Audit and Metrics to Drive Performance

      • Connections that Matter

    • Going Wide-Global Strategies

      • Site DI Officers

      • Grassroots Teams

      • Data Integrity Council

      • Questions and Answers


  • 3:00 PM - 3:15 PM
  • Mid-Afternoon Refreshment Break

  • 3:15 PM - 4:00 PM
  • What is a Risk Based Approach for Audit Trail Review?

    Cozette Cuppett, Principal Director Americas Field Marketing, Waters Corporation, Milford, MA

    Since Annex 11 first raised in regulation the need for audit trail review there has been much discussion in industry about how to ensure that the information contained in electronic audit trails is reviewed along with the actual data and other metadata. Within the regulatory authority data integrity guidance documents there appears to be a mixture of expectations including some truly non risk-based approaches indicating a need for 100% review. In many companies, audit trail review is always a part of any data review standard operating procedure (SOP). Some companies have since attempted to create a separate audit trail review SOP, without much thought to the quality and value this exercise adds.

    This presentation will:

    • Review the various released and draft guidance documents for this topic

    • Discuss the kinds of records that make up an electronic audit trail

    • Look at the challenges and practical approaches, both to the actual review process and the method of documentation of that review


  • 4:00 PM – 4:15PM
  • Panel Q & A
    Chris Wubbolt, Principal Consultant, QACV Consulting
    Chris Binion, Manager, Global Quality , Corporate, Data Integrity Compliance, Officer, Patheon
    Cozette Cuppett, Principal Director Americas Field Marketing, Waters Corporation, Milford, MA

  • 4:15 PM – 4:45 PM
  • Interactive Panel Discussions (Submit your questions prior to the conference to be discussed)
    Discussion with all available speakers

  • 4:45 PM
  • Conclusion of Day 1

    Note: Agenda is subject to change without notice. Please check back regularly for updates.

  • 8:15 AM – 8:55 AM
  • Continental Breakfast and Exhibition Viewing

  • 8:55 AM – 9:00 AM
  • Chair’s Welcome Note
    Natasha Demberg, BSc, MSc, Vice President of Pharmaceutical Solutions, Neopharm Labs

  • 9:00 AM – 10:15 AM
  • Improve Data Integrity Practices from Real-Life Examples

    Chris Wubbolt, Principal Consultant, QACV Consulting

    • Data integrity examples will be discussed

      • Examples of data integrity issues will be presented

      • How were the issues were identified?

      • Mitigation measures required to reduce or eliminate data integrity risk

    • Measures to Detect Data Integrity Issues

      • Discuss approaches to detecting data integrity issues within your organization

      • Review data lifecycle and data flows to allow detection of data integrity issues

      • Controls necessary to prevent data integrity issues

    • Interactive Discussion

      • Group participation in discussing data integrity challenges within their organizations


  • 10:15 AM - 11:00 AM
  • Data Integrity Issues in Manufacturing – Prevention and Remediation

    James P. Stumpff, RPh, Principal Consultant, PAREXEL International, Former FDA

    • Common data integrity issues in Manufacturing

    • Strategies for prevention of data integrity issues

    • Remediation of data integrity issues


  • 11:00 AM – 11:15 AM
  • Mid-morning Refreshment Break & Exhibition viewing

  • 11:15 AM – 12:15 PM
  • Validation of Software and Computer Systems

    Oleg Trigub, Director, Global IT Quality, Covance

    This presentation will discuss the requirements for computerized system validation (CSV), and will explain how systems should be developed and/or implemented, controlled, and maintained. Topics will include:

    • Regulatory applicability for qualification and CSV

    • Aspects of computerized systems (hardware, software, infrastructure, and operating environments)

    • How validation phases apply to different types of system development cycles (SDLC)

    • Roles and responsibilities

    • Assessing risk and determining scope of validation

    • More on electronic records and signatures and data integrity and respective automated and procedural controls


  • 12:15 PM -12:30 PM
  • Panel Q & A
    Chris Wubbolt, Principal Consultant, QACV Consulting
    James P. Stumpff, RPh, Principal Consultant, PAREXEL International, Former FDA
    Oleg Trigub, Director, Global IT Quality, Covance

  • 12:30 PM -1:30 PM
  • Networking Lunch & Exhibition viewing

  • 1:30 PM - 2:30 PM
  • Laboratory Data Integrity in Computer Systems

    Chris Wubbolt, Principal Consultant, QACV Consulting

    • Understand the Data Integrity Lifecycle

      • What is data integrity?

      • What does data integrity lifecycle mean?

      • Learn the components of data integrity and how data moves throughout its lifecycle

      • What is Data Security?

    • What is Electronic Record/Electronic Signatures (ER/ES)?

      • What is electronic records?

      • What is electronic signatures?

      • When does ER/ES apply?

      • Learn the fundamentals of ER/ES and how it applies to laboratory data

    • Controls for Electronic Data

      • What are electronic data controls?

      • Where are data controls required?

      • Learn how to implement data controls

      • Apply controls to the various computer system platforms


  • 2:30 PM – 3:15 PM
  • Auditing for Data Integrity---Why and How

    Barbara W. Unger, B.S., UNGER CONSULTING, Inc.

    The routine quality system approach to auditing can frequently fail to identify data management and data integrity problems. To address this problem, it may be time to consider a dramatic change in approach to some types of GMP auditing driven by the premise that if we cannot trust the data generated by a firm under audit, why would we want to do business with them? This presentation will provide examples of where auditing for data governance and data integrity is superior to taking a quality systems approach where time and personnel are limited.

    In addition, I will provide some features of effective data integrity audits:

    • Standards for Assessing Data Governance and Data Integrity

    • Auditor Expertise

    • Simple Deficiencies In Process And Procedures Have Not Been Corrected Since FDA Began Identifying Them 15 Years Ago, Where To Look


  • 3:15 PM – 3:30 PM
  • Mid-Afternoon Refreshment Break & Exhibition viewing

  • 3:30 PM - 4:00 PM
  • Interactive Discussion on: Data Integrity Risk Assessment and Remediation
    Chris Binion, Manager, Global Quality , Corporate, Data Integrity Compliance, Officer, Patheon

  • 4:00 PM - 4:30 PM
  • Panel Q & A
    Chris Wubbolt, Principal Consultant, QACV Consulting
    Barbara W. Unger, B.S., UNGER CONSULTING, Inc.

    Chris Binion, Manager, Global Quality , Corporate, Data Integrity Compliance, Officer, Patheon

    Interactive Panel Discussions (Submit your questions prior to the conference to be discussed)
    Discussions with all available Speakers

  • 4:30 PM
  • Conclusion of Day 1

    Note: Agenda is subject to change without notice. Please check back regularly for updates.