Computer System Validation (CSV) and GAMP 5

In regulated pharmaceutical environments, computerized systems are essential for ensuring product quality, data integrity, and patient safety. Computer System Validation (CSV) provides documented evidence that these systems perform reliably, securely, and in compliance with regulations such as FDA 21 CFR Part 11 and EU Annex 11.

By completing this course, you will gain the knowledge to implement effective CSV practices, manage validation documentation, and ensure compliance with regulatory standards while supporting consistent, high-quality operations.

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

✅ Who should enroll?

• Quality assurance and validation professionals
• IT and systems specialists in pharmaceutical and biotech companies
• Regulatory affairs personnel overseeing computerized systems
• Project managers involved in system implementation and validation

🎯 What you’ll learn?

• Importance and role of CSV in regulated industries
• Key phases of the CSV lifecycle: concept, project, operation, retirement
• Best practices for validation planning, documentation, and quality assurance
• Classification of software and hardware components per GAMP®5 guidelines
• Development and use of essential validation documents such as CDS and validation plans

Curriculum:

Introduction
Lesson 1: Introduction to GAMP 5 Guidelines for CSV
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