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Session 6 Track 3: Strategies for Ensuring Part 11/Annex 11 Compliance of eTMFs at Research Sites
Session Chair(s)
James Riddle
Senior Vice President, Global Review Operations
Advarra, United States
Don’t be caught off guard with a preventable compliance finding. Building a risk-based Part 11/Annex 11 compliance program at research sites is easier than most think. FDA has made it clear in recent draft guidance that electronic regulatory master files and other ‘e’ systems are subject to Part 11 regulations. All parties need to understand the requirements and develop strategies for compliance.
Learning Objective : Upon completion of this session, the participant should be able to:
- Understand basics of when Part 11 applies
- Explain where to find additional information and resources
- Activate programs and systems to prepare for Part 11 inspection
Speaker(s)
Brief Overview of Part 11/Annex 11 and Implications for Research Sites
James Riddle
Advarra, United States
Senior Vice President, Global Review Operations
Speaker
Darren Lacey
Johns Hopkins University, United States
Chief Information Security Officer
Speaker
Lawrence Rich
Gxp Authority, United States
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