Computerized System Validation is one of the most important quality and compliance disciplines in regulated pharmaceutical environments. Companies worldwide rely on CSV professionals to ensure that computerized systems are compliant with regulations such as FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, ALCOA+, and Data Integrity requirements.
In this course, you’ll learn CSV from the ground up using a structured and easy-to-understand approach. Rather than memorizing definitions, you’ll understand why validation is required, how real pharmaceutical companies implement CSV, and what recruiters expect from professionals entering this field.
Throughout the course, you’ll explore:
- Fundamentals of Computerized System Validation (CSV)
- GxP Regulations and Regulatory Compliance
- FDA 21 CFR Part 11
- EU GMP Annex 11
- ALCOA+ Data Integrity Principles
- GAMP 5 Fundamentals
- CSV Lifecycle






