Gain a recognized and traceable certificate after completing the course :
All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.
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.
In this course, we provide a synthesis on the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
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