Computer System
Validation in FDA-regulated Industries
Seminar Agenda
Day 1
AM 9:00 – noon
v Introduction: Session Agenda and Goals, Participant
Introductions
v Validation Overview
– Key Validation Terminology
– Reasons & Motivations for addressing Validation
– Validation Mind Set - Activity
v Validation Process
v Validation Plan
– Contents
– Developing the Plan - Activity
PM 1:00 – 5:00
v Risk Management
– Assessment
– Mitigation
v System Development
– Alternative Life Cycle Methodologies
– Deliverables
– Standards
– Assessing development activities
v System Installation
v Testing
– Phases
– Process
– Test Types & Tools
Day 2
AM 9:00 – noon
v Day 1 Recap - Questions & Answers, Day 2 Plan
v Introduction to Computerized System (used during the
Activities)
v User Acceptance Test Plan
– Contents
– Techniques for Plan Development
v Plan Development - Activity
v Script Development & Test Execution
– Report Evaluation - Activity
v Security Issues - Activity
v Traceability Analysis/Traceability Matrix
PM 1:00 – 5:00
v Validation Report
v Validation File Documentation - Activity
v Change Management
v Regulatory Impact
– FDA Regulatory Requirements for Validation
– Guidance Documents
– Regulatory Actions for Non-compliance
– 483s - Activity
v Wrap-up
