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Regulatory Submissions, Information, and Document Management Forum


Session 6 Track 3: Strategies for Ensuring Part 11/Annex 11 Compliance of eTMFs at Research Sites

    Session Chair(s)
      James  Riddle, MS

      James Riddle, MS

      • Vice President of Client Services
      • Kinetiq, a Division of Quorum IRB, 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 FDA has made it clear in recent draft guidance that electronic regulatory master files and other ‘e’ systems are subject to Part 11 regulations.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)
      James  Riddle, MS

      Brief Overview of Part 11/Annex 11 and Implications for Research Sites

      James Riddle, MS

      • Vice President of Client Services
      • Kinetiq, a Division of Quorum IRB, United States
      Representative Invited

      Speaker

      Representative Invited

      • Johns Hopkins University, United States
      Representative Invited

      Speaker

      Representative Invited

      • FDA, United States