Production systems for the life science industry must comply with increasingly stricter regulations. Every pharmaceutical and medical device company producing for the European or American market is subject to EMA and FDA requirements and/or local legislation.
Aside from the legislation, the technologies and possibilities used keep evolving at an increasing speed. Computer systems are integrated with each other, creating a more complex landscape, which could not be imagined before.
GAMP (Good Automated Manufacturing Practice), is not another legislation, but a practical interpretation of the legislation and is seen as a structured and project-based approach for validating computer systems.
The latest GAMP5® second edition update emphasizes the importance of computer system assurance above computer system validation.
This in-depth 4-session training will provide you with a fundamental basis to engage yourself in Computer System Validation (CSV) projects and will show you the differences in focus between CSV and Computer System Assurance (CSA).