Risk
Management
Applied to Computer System Validation
Seminar Agenda
AM 9:00 – noon
v Introduction
– Agenda and Session Goals
- Guidance Sources/Approaches
v Risk Management Overview
– Risk Assessment
- Risk Mitigation
v Risk Management Process
- Process Introduction
– Impact on Computer System Validation
- Documentation Templates
PM 1:00 – 5:00
v 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
- On-going Risk Management
v Wrap-up
