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Pharmaceutical Computer Validation Introduction Manual and CD, GMP (Good Manufacturing Practices) Training Introduction To Meet FDA Regulations in the ... on Computer System Validation and Part 11

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Item description for Pharmaceutical Computer Validation Introduction Manual and CD, GMP (Good Manufacturing Practices) Training Introduction To Meet FDA Regulations in the ... on Computer System Validation and Part 11 by Daniel Farb...

Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, and so on.




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Item Specifications...


Pages   259
Est. Packaging Dimensions:   Length: 8.82" Width: 6.06" Height: 0.39"
Weight:   0.44 lbs.
Binding  Ring Bound
Publisher   UniversityOfHealthCare
ISBN  1932634673  
ISBN13  9781932634679  


Availability  0 units.


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Product Categories

1Books > Subjects > Medicine > Education & Training > General
2Books > Subjects > Medicine > General
3Books > Subjects > Medicine > Pharmacology > Pharmacy
4Books > Subjects > Professional & Technical > Medical > Pharmacology > Pharmacy
5Books > Subjects > Science > General



Reviews - What do customers think about Pharmaceutical Computer Validation Introduction Manual and CD, GMP (Good Manufacturing Practices) Training Introduction To Meet FDA Regulations in the ... on Computer System Validation and Part 11?

dismal & disappointing  May 7, 2004
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.
 

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