GAMP 5 & Computer Systems Validation (CSV)

These two day courses introduce participants to Computer Systems Validation (CSV) and GAMP 5 – the methods and tools used to ensure compliance for computerized systems in the life sciences industry.

Click one of the course dates below to learn more!

Computer Systems Validation (also known as computer validation, or CSV) is the process of documenting that a computer system meets a set of defined system requirements. 

The validation of IT systems is extremely important in heavily regulated industries, like the life sciences. Through the use of Good Automated Manufacturing Practice (GAMP), you'll learn how to follow a systematic approach to the categorization, documentation, and risk assessment of automated systems.

By taking a course at Pharma IT Academy, you'll feel confident in your fundamental understanding of how to validate IT systems and your ability to use course concepts in practice. You'll learn GAMP® 5, EudraLex Vol. 4 Annex 11, and 21 CFR Part 11 – with a strong focus on documentation, validation, data integrity, and compliance. 

Our courses are taught by industry veterans with decades of experience. You can count on our experts Dorte Juul and Stine Kristensen to provide the most up-to-date regulatory insights and practical expertise. Course teaching style includes both a theoretical basis, case-based activities, and take-home templates that can be used in your daily work long after the course time. 

Click on one of the upcoming course dates above to learn more!