| #3050366 in Books | 2001-12-27 | Original language:English | PDF # 1 | 9.68 x.65 x6.14l,.97 | File type: PDF | 208 pages||2 of 5 people found the following review helpful.| Master Validation Plan|By Bhadresh|I have reviewed this excellent book. This book guides you through all process required for validation from FDA. In new edition, the author should give more details and technical guidance for control systems and software validation. Also to help in 21 CFR 11 approval. CD-ROM with the book is a help to cut down all the time wasted in formatting
The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceut...
You easily download any file type for your gadget.Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance | Syed Imtiaz Haider. I was recommended this book by a dear friend of mine.
