Computer System Validation (CSV)

By taking this course, you will gain a comprehensive understanding of Computer System Validation (CSV), its significance in regulated industries, and the associated regulations and standards. The course will equip you with recommendations and best practices for successful CSV implementation, as well as an understanding of the GAMP®5 framework and the essential competencies required for a validation team. At the end of the course, you will have the knowledge and skills necessary to effectively manage electronic data in a regulated environment while ensuring compliance with regulatory guideline such as FDA’s 21 CFR Part 11 and EU Annex 11.

Curriculum:

Introduction

Lesson 1: Introduction to GAMP 5 Guidelines for CSV

• Roles and Responsibilities

Lesson 2: Validation Process in CSV

Lesson 3: Phase 1 of CSV – Concept Phase

Lesson 4: Phase 2 of CSV – Project Phase

Lesson 5: Phase 3 of CSV – Operation Phase

Lesson 6: Phase 4 of CSV – Retirement Phase

Lesson 7: Multi-Phase and Checklist for CSV

Glossary

Evaluation