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Session 9: Track 3: Ensuring Part 11/Annex 11 Compliance at Research Sites
Session Chair(s)
Joanne Malia, MS, MSc
Director, Development Records Management
Regeneron Pharmaceuticals, United States
With the proliferation of electronic trial master files (eTMFs), electronic consent (eConsent) and other electronic regulatory document management systems in use at sites, sponsors and CROs are at risk of compliance findings if they do not have strategies in place to ensure sites comply with 21 CFR 11 and Annex 11 regulations. In this session we will discuss various aspects and best practices for helping sites build an appropriate risk based approach to Part 11 compliance for their “eSystems”. Tools will be explored to help sites understand their commitments and document their compliance with the appropriate regulation.
Learning Objective : At the conclusion of this session, participants should be able to:/UL>
Speaker(s)
Ensuring Part 11/Annex 11 Compliance at Research Sites
James Riddle
Advarra, United States
Senior Vice President, Global Review Operations
Preparing Research Sites for eSource with Part 11 Compliant Tools
Raymond Nomizu, JD
CRIO, United States
CEO
Case Examples of the Review of Data Integrity Controls in GCP Inspections
Cheryl Grandinetti, PharmD
FDA, United States
Clinical Pharmacologist, OSI, OC, CDER