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FDA Inspection of Clinical Data Systems


Course Agenda

Day One
Overview
  • Inspection Fundamentals
  • Revisiting Quality Procedures
  • Prepping the System
  • Preparing for the Inspection
  • Keeping Compliant
Inspection Fundamentals
  • Principles of Inspection
      -Responsibilities
      -General Inspection vs. Targeted Inspection
      -Checklist

  • Computer System Validation Issue
      -CSV Deliverables
      -Functional vs. User Acceptance Testing - What's the difference?
      -Traceability Requirements
      -Infrastructure Requirements
      -Data Management Concerns
  • 21 CFR Part 11 Issue
    -Intent to Use ERES
    -Inventory
    -Assessment and Remediation Plans
    -State of the System(s)
    Revisiting Quality Procedures
    • Expected System Procedures and Processes
    • Expected Data Quality Procedures
    • Expected Operations Management Procedures
    • Addressing the Gaps

    Day Two

    Revisiting System Documentation
    • Performing a Gap Analysis -What is missing?
    • Filling in the Evidence Gap - Selective Testing Approaches
    • Retrospective vs. Prospective Activities
    • Example - Clintrial/Oracle Clinical
    Preparing for the Inspection
    • Responsibilities
    • Hard Questions - A matter of readiness! 
    • Mock Audits/Internal System Audit
    Keeping Compliant
    • Responsibilities
    • Moving to a Proactive Approach - Improving Your Systems Quality program

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