Validation Books

Too short to be usefull. Save your cash. Don't buy it.

Well,

Some interesting and unproved ideas, presented in a largely unconvincing (to me) manner. I believe that anyone considering taking glyconutrients should ask themselves why the product is sold by one company through a multi-level marketing program, and why there is limited or non-existent third party corroboration of its efficacy. As the saying goes "caveat emptor" ...

With such a glowing resume, I'd expect a book from Dr. Farb with more substance.
It is a 111-page book. BUT only the first 33 pages are original content. The first part of the book is basically a "story" about dueling computers and in the process try to introduce ideas of computer validation. The "story" doesn't make much sense in regard to computer validation. The concepts are introduced at a thirty thousand-foot high level, sprinkled with "review questions" that are so obvious you don't need to read the book to get them right. You can skim through the entire "story" in about 20 minutes, and what you learn about computer validation you can find for free on the internet, especially when the information is presented at such a high level.

So what happened after the first 30-some pages? The rest of the book contains sections from various FDA documents thrown together with no organization whatsoever. So you get over 70 pages of documents (in small print) that you can download FOR FREE from the FDA site! And the way the documents are presented, you don't know when one document ends and the other one begins. Completely unorganized. Just a bunch of text thrown together and you'll need to figure out what's going on.

The book doesn't provide any context of why these particular FDA documents are included, how they are related to each other, when they are applicable etc. Nothing. And worst of all, some of the the documents are outdated already!

Consider this book is meant to be an introduction guidebook, I'd assume there will be more explanation included.

There is a CD ROM version that I believe costs a lot more. You definitely DO NOT want the CD ROM version.

This books is a major disappoinment.

I bought this manual and CD as I looked for a source to learn (more) abou FDA regulations and GMP validation from an IT Managers perspective. This seemed to be a good start despite the fact it is rather expensive. My first disappointment came when I opened the package to discover "the manual". You can get copies of FDA regulations for free. Here you have to pay for a copy in poor quality print in very small font and all wrapped up with a cheap plastic ring the kind you use to bundle your next in-house powerpoint presentation.
I hoped the CD would be better, but discovered it only contains some 150 screens, several only displaying useless cartoons of 'angry' or 'happy' computer screens. The training "story" doesn't make any sense, navigation thru the material is extremely poor and you learn nothing new about validation unless you really didn't have a clue what it was all about in the first place. I read thru the whole material in 90 minutes; correctly answering the tests and checks was a no-brainer and when I eventually reached the "exam", it guided me to the page where I could print my "certificate", after answering the first question correctly!
This stuff is a waste of time and money.

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....