During this discussion, we will try to comply the requirements of 21CFR Part 11, EU GMP annex 11 and approach by GAMP guide. Further we will understand difference between GAMP4 & GAMP5 guide. We will have some practical insight on CSV during our discussion.
Dharmesh Mehta
Cadila, Sanofi,Zydus, AstraZeneca,Mylan,Interview Questions with Sharma Ji,ASK Mechnology,emainfo,Qualistery - GMP Content,easy medical device
Негізгі бет Brief on Computerized System Validation
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