Customer Reviews

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition

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First of all - no index.
Second - the CD has examples that are poorly and inconsistently formatted. To use them, you'd have to spend time formatting everything. They should have used fonts, styles, etc. that are used in standard documents.
Thirdly - the book is huge so you'd expect more information on what to put in a Purpose, a Scope, etc. You don't get that. Instead you get a bunch of examples that must have been pulled from one or two companies.
If you are a professional writer like me, you don't want to waste time. You want something in template format that you can easily adapt to your company's product.
If there had been a review of this - I never would have bought it. I'm sorry but this book could have used an Editor. It was so disappointing and I'm so happy that Amazon understood my feelings and accepted the return of this book.
For a potential writer - here is a market! There are startup or small biotech/biomed companies that are trying to meet FDA regulations on SOPs and other related documents. Write a book and provide a CD with decent templates and examples! Hey, maybe I should do that. Good luck. I haven't found any other book that would help either....