Computer System Validation in

FDA-regulated Industries

Seminar Agenda

Day 1
 

AM

v         Introduction

–        Session Agenda & Goals

–        Participant Introductions

v         Validation Overview

            –    Key Validation Terminology

            –    Reasons and Motivations for addressing Validation

            –    Validation Mind Set Activity

v         Validation Process

v         Validation Plan

            –    Contents

            –    Developing the Plan Activity

PM

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

v         Day 1 Recap – Questions & Answers, Day 2 Plan

v         Introduction to a Computerized System (used during the Activities)

v         User Acceptance Test Plan

            –    Contents

–        Techniques for Plan Development

v         Plan Development Activity

v                 Test Scripts

–        Development & Execution

–        Report Evaluation Activity

v                 Security Issues Activity

v                 Traceability Analysis/Traceability Matrix

PM

v         Validation Report

v                 Validation File Documentation Activity

v                 Tailoring the Validation Process

v                 Change Management

v                 Regulatory Impact

            –    FDA Regulatory Requirements for Validation

–        Guidance Documents

–        Regulatory Actions for Non-compliance

–        483 Activity

v                 Wrap-up

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