This course focuses on GMP requirements as they relate to CS, as well as interpretations of and compliance with these requirements. The course is aimed at QA staff and anyone else involved in qualifying/validating CS. The course is also suitable for support staff with a need to familiarize themselves with the IT-specific GMP requirements.
THEME: General requirements/CS validation
THEME: Part 11 – Electronic Records/Electronic Signatures (ER/ES)
THEME: Data integrity
Both course days also include a review of relevant warning letters.
The aim of the course is to increase participants’ knowledge of:
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