Risk Management
Applied to Computer System Validation

Seminar Agenda

AM

v         Introduction

            –    Agenda & 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

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

–        Ongoing Risk Management

v         Wrap-up

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