Data Integrity Workshop, 5 June 2016, Bethesda, MD

Data Integrity Workshop

FDA’s draft guidance on Data Integrity is published – is your company ready?

Sarah Barkow Photograph

Sarah Barkow PhD
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Get your questions answered from Sarah Barkow, Team Lead and Consumer Safety Officer at FDA and Co-leader of the FDA’s new draft guidance “Data Integrity and Compliance With CGMP Guidance for Industry” at ISPE's 2016 Data Integrity Workshop on 5 June. This timely workshop will clarify for the attendees the relationship between CGMP, metadata, audit trail, static and dynamic record formats, and backup in computer related systems and clarify good manufacturing practice (CGMP) violations involving data integrity during CGMP inspections. This guidance is an opportunity to explain FDA’s current thinking on the topic of data integrity and compliance with CGMP.

Other hands-on, interactive sessions, on how to identify, mitigate, and remediate potential causes of breaches in data integrity at the workshop:

Overview of Data Integrity and its Key Components:

  • Application Integrity Policy
  • Review of Recent Regulatory Actions
  • Laboratory and Manufacturing
  • Data Governance including Computer Systems
  • Regional and Corporate including Human Factor

Interactive Fact Pattern Breakouts Sessions designed to improve skills in:

  • Identifying potential data integrity issues
  • Understanding common causes of data integrity breaches
  • Improving critical thinking on conducting a data integrity investigation
  • Linking data integrity findings to product quality impact

Special Session on Industry Best Practices and Mitigation Strategies, including Management Accountability, Data Integrity as key element of QMS/CSV and Audit and Assessment.

Participate in discussions and learn from these knowledgeable regulators and industry experts on how data integrity directly impacts product related decisions and traceability:

  • Sarah R. Barkow, PhD, Team Lead, Manufacturing Quality Guidance and Policy Staff, FDA/CDER/OC/OMQ
  • James Davidson, PhD, VP, Science and Technology Practice Lachman Consultant Services
  • Karen Hirshfield, RPh, Senior Principal Compliance Specialist, Genentech Inc., A Member of the Roche Group
  • Stephen Mahoney, JD, Senior Director, Global Quality & Compliance , Genentech Inc., A Member of the Roche Group
  • Mark Newton, Associate Senior Consultant, Eli Lilly and Company
  • Barry Rothman, Director, Compliance Practice, Lachman Consultant Services
  • Michael Rutherford, Consultant - Laboratory and Quality Systems Medicines Development Unit (MDU), Eli Lilly and Company
  • Lorrie Schuessler, Manager, Computer Systems and Quality Assurance, GlaxoSmithKline
  • Aditi Thakur, Chemist, FDA/CDER/OPQ/OPF/DIA
  • Sion Wyn, Director, Conformity Ltd.

Don’t miss ISPE's special half-day Data Integrity Workshop focused on key data integrity issues, such as current regulatory environment's impact, data governance and corporate and regional culture, facing the pharmaceutical product lifecycle. This interactive workshop will identify and answer key questions surrounding current expectations, and provide an overview of the Application Integrity Policy.  The Data Integrity Workshop will be held in conjunction with the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference, 6–8 June 2016 (separate registration is required).

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Schedule for Sunday, 5 June 2016

12.30 – 12:40 Welcome and Opening Remarks
12.40 – 14.15

Overview, Current Expectations of Data Integrity:

  • History of Data Integrity
  • Current Expectations and Guidance
  • Key Data Integrity Issues
14.15 – 15.30 Fact Pattern Breakout Sessions
15.30 – 16.00 Networking Break
16.00 – 16.30 Reporting from Breakout Sessions
16.30 – 17.15 Industry Best Practices/Mitigation Strategies
17.15 – 17.30 Wrap-up for Key takeaways
17.30 – 18.30 Reception (Sponsored by Genentech)

ISPE/FDA/PQRI Quality Manufacturing Conference

Three organizations have joined forces, once again, to offer you the most comprehensive manufacturing quality conference in the pharmaceutical industry. Hear first-hand from global regulators, who will provide you with invaluable insights as your company attempts to navigate the increasingly complex nature of regulatory compliance and quality expectations. Plus, it is a savings of $100 if you register for Data Integrity Workshop and Quality Manufacturing Conference, which are being held at the same venue.

On-site Guide
View the On-site Guide

Newly Released FDA Draft Guidance on Data Integrity

Data Integrity and Compliance With CGMP Guidance for Industry »

Thank you to our Program Committee!

  • Chair: Frances Zipp, Presient and CEO, Lachman Consultant Services
  • Co-Chair: Stephen Mahoney, Senior Director, Global Quality & Compliance, Genentech/Roche

Program Committee Members

  • James Davidson, Vice President, Science and Technology Practice, Lachman Consultant Services
  • Joe Famulare, Vice President, Global Compliance and External Collaboration, Genentech/Roche
  • Karen Hirshfield, Senior Compliance Specialist, Genentech/Roche
  • Chris Reid, CEO, Integrity Solutions Ltd.
  • Michael Rutherford, Consultant, MDU Business Systems, Eli Lilly & Co.

Conference Sponsor