Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance

Rating:
Summary: No actual content
Review: 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 information and make templtes for crtical forms. Congratulations for writing this exceelent book.

Rating:
Summary: Master Validation Plan
Review: 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 information and make templtes for crtical forms. Congratulations for writing this exceelent book.

Rating:
Summary: No actual content
Review: I'm sorry to report that this book merely presents an outline of steps to take, along with a collection of document templates, neither of which contain any actual "content". In other words, it tells you "what", but not "how". If you're looking for insight and real-world examples, look elsewhere. I couldn't justify a bunch of blank forms and outlines for such a cover-price. I sent mine back and Amazon graciously refunded my money.