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Workshop C: TMF Inspection Readiness

10 Sep 2019

Workshop C: TMF Inspection Readiness

Ensuring a successful inspection is critical to the success of a clinical study. This workshop will guide you through the process to ensure that your documentation, whether TMF or eTMF is inspection ready utilizing correct approaches and industry best practices. Topics to be covered include:

    • Regulatory framework for inspections
    • Who is involved?
    • How do inspections occur?
    • TMF/eTMF inspection preparation
      • Document management
      • Making files available
      • Defined roles & responsibilities
      • Governance & training
      • Systems validation
      • Future proofing
      • Ensuring 100% inspection readiness
    • What are inspectors looking for?
    • Electronic versus hard copy files
    • Findings & impacts
    • Post inspection
      • Responding to findings
      • CAPA
      • Improving compliance for the future


  • Avoiding failed TMF inspections
  • Q&A