Risk Management Applied to Computer System Validation


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This 1-day seminar reviews the FDA regulations and industry guidance on risk assessment including GAMP, NIST, and ISO. The seminar addresses the process to complete Risk Assessment and Risk Mitigation activities as applied to computer system validation.

Participants learn how to:

  • Identify risks as part of the validation planning process
  • Develop mitigation strategies
  • Evaluate residual risk
  • Prepare a Risk Assessment Report and address on-going risk management

The Registration Fee includes attendance, continental breakfast, lunch, and breaks, and an attendee binder containing slides, handouts, and activities.

Additional information

Dates Offered:

May 04, 2017 Feasterville, PA, November 09, 2017 Feasterville, PA


  • Introduction
    • Agenda & session goals
    • Guidance Sources/Approaches
  • Risk Management Overview
    • Risk Assessment
    • Risk Mitigation
  • Risk Management Process
    • Process Introduction
    • Impact on Computer System Validation
    • Documentation Templates

  • Risk Management Process (continued)
    • Phase I: determination of risk appropriate validation strategies
    • Phase II: identification of development approach and level of testing based on risk
    • Phase III: residual risk evaluation and mitigation
    • Ongoing Risk Management
  • Wrap-up