This one-day intensive course is aimed at quality assurance professionals, regulatory affairs managers, IT staff, and computer system validation engineers involved in the manufacture of medical or pharmaceutical products. We take an in-depth look at the essential requirements of ISO 13485 for computer system validation (CSV) and the FDA’s current thinking on CSV, including the implications of the Final Rule on 21 CFR Part 820. A particular focus is on the rapidly evolving landscape of artificial intelligence (AI) and cloud-based applications in business.

You would like to perform the training inhouse? We fit the contents individually to your needs!

Dates

This training is conducted by our cooperation partner “Quality Assurance and Statistics.”
Details and information on dates, prices, and registration can be found on our cooperation partner’s website. (in German only)