Data Integrity Workshop, 517 June, Marriott Crystal Gateway, Arlington, VA

Data Integrity Education

The half-day Data Integrity workshop will be a combination of general and breakout sessions, and panel discussions, facilitated by data integrity experts, providing participants an opportunity to apply their acquired data integrity knowledge to realistic scenarios. Attendees will have the opportunity to interact with regulatory and pharmaceutical industry experts in a small group setting to identify data integrity gaps and risks facing our industry today, understand assessment and mitigation approaches and strategies, and learn processes and tools they can immediately apply in their work areas. The workshop will conclude with an interactive attendee Q&A panel discussion with regulatory and pharmaceutical industry experts to further enhance the participant’s understanding of data integrity expectations and compliance strategies.

Core Workshop Topics for 2017:

  • Process Workflows/Data Mapping with emphasis on data flow diagrams as visual tools to help show the relationships of a business activity, including the creation and movement of data through that activity
  • Data Review/Forensic Tools focusing on chromatography in labs and use of audit trails in manufacturing
  • Data Integrity Governance including organizational maturity and cultural implications, developing metrics to enable the creation of a Data Integrity Governance checklist
  • Case Studies from the NEW ISPE GAMP® Guide: Records and Data Integrity will be interspersed within the sessions

Conference Schedule

Sunday, 4 June

12:30 - 12:45  Welcome and Opening Remarks
  • Frances Zipp, President & CEO, Lachman Consultant Services, USA
    Welcome and Opening Remarks
12:45 - 13:15  Overview of Breakout Session Topics
  • Michael Rutherford, Consultant - Laboratory and Quality Systems, Eli Lilly and Company, USA
    An Introduction to the ISPE GAMP Records and Data Integrity Guide and the Workshop Breakout Sessions
13:15 - 14:45  Process Workflows and Data Mapping
13:15 - 14:45  Data Review and Forensic Tools
  • Moderator: Daniel Barreto, Vice President, Lachman Consultant Services, USA
    Data Review and Forensic Tools
  • Moderator: Heather Longden, Sr Mktg Mgr, Info-Regulatory Compliance, Waters, USA
    Data Review and Forensic Tools
  • Moderator: Michael Rutherford, Consultant - Laboratory and Quality Systems, Eli Lilly and Company, USA
    Data Review/Forensic Tools
13:15 - 14:45  Data Integrity Governance
14:45 - 15:15  Break
15:15 - 16:45  Data Mapping and Data Flow
15:15 - 16:45  Data Review and Forensic Tools
15:15 - 16:45  Data Integrity Governance
16:45 - 17:30  Panel Discussion
  • Sarah Barkow, PhD, Team Lead, FDA/CDER/OC/OMQ, USA
  • Michael Rutherford, Consultant - Laboratory and Quality Systems, Eli Lilly and Company, USA
  • Karen Takahashi, Senior Policy Advisor, FDA/CDER/OPQ/OPPQ/DRGS/CO, USA, Invited
  • Frances Zipp, President & CEO, Lachman Consultant Services, USA
  • Moderator: Stephen Mahoney, JD, Senior Advisor, Global Quality & Compliance, Genentech/Roche Inc, USA
17:30 - 18:30  Reception

Presentations & Attendee Roster

Conference Attendees:

Featured Speakers

Sarah Barkow, PhD. Photograph
Sarah Barkow, PhD.
Team lead, Manufacturing Quality Guidance and Policy Staff
FDA/CDER/OC/OMQ
James Davidson Photograph
James Davidson, PhD.
Vice President, Science and Technology Practice
Lachman Consultant Services
Heather Longden Photograph
Heather Longden
Senior Marketing Manager, Informatics and Regulatory Compliance
Waters Corporation
Mark Newton Photograph
Mark Newton
Associate Senior Consultant
Eli Lilly and Company

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