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Title: Pharmaceutical Computer Validation Introduction: Gmp (Good Manufacturing Practices) Training Introduction to Meet Fda Regulations in the Use of Computers in Pharmaceutical, Medical Device, Food, and by Daniel, Md Farb, Bruce Gordon ISBN: 1-59491-036-7 Publisher: Universityofhealthcare Pub. Date: June, 2004 Format: Paperback List Price(USD): $199.95

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Average Customer Rating: 1 (1 review)

Rating: 1
Summary: dismal & disappointing
Comment: 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.