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Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations
 
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Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations [Paperback]

Carol Desain (Author)

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Product Details

  • Paperback: 124 pages
  • Publisher: Advanstar Communications; 2nd edition (April 15 2002)
  • Language: English
  • ISBN-10: 092987062X
  • ISBN-13: 978-0929870625
  • Product Dimensions: 27.7 x 21.5 x 0.9 cm
  • Shipping Weight: 413 g
  • Amazon Bestsellers Rank: #2,147,569 in Books (See Top 100 in Books)

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Product Description

Book Description

A comprehensive reference that includes data about establishing company-wide documentation systems, this information will allow businesses to meet good manufacturing practices and quality system regulations. Provided is a minimum set of standards to consider when designing document identification numbering systems or writing standard operating procedures, specifications, quality manuals, and logbooks. Those benefiting from this might be the medical products industry that develops diagnostic or biologic products, technicians who manufacture, test, package, and distribute products for commercial use, and those who train new employees in the basic requirements for GMP/QSR-compliant documentation.

About the Author

Carol DeSain is the author of Documentation Practices and Risk Management Basics. She lives in Tofte, Minnesota.

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Amazon.com: 4.5 out of 5 stars (4 customer reviews)

2 of 2 people found the following review helpful
5.0 out of 5 stars A Must Have for any QA person, Mar 27 2009
By T. Williams - Published on Amazon.com
Amazon Verified Purchase(What's this?)
The book is excellent. I only wish I had it 3 years ago when I started in QA. It is a basics book. There isnt a lot of detail but it is a good frame work for starting a regulated or soon to be regulated company.

2 of 2 people found the following review helpful
5.0 out of 5 stars Whooeee! Some reading!, Jan 7 2007
By Buckman - Published on Amazon.com
Amazon Verified Purchase(What's this?)
I'm in a Good Manufacturing Practices environment and my manager, the head of Manufacturing Quality Assurance, kept mentioning this book and referencing it in her Standard Operating Procedure documents. It's expensive, but it is a textbook and a reference book. This book has been the gold standard for 20 years or so. You'll want to read through it completely. Then, after that, it is good reading to keep in your car or work desk for those times when you have a few minutes to spare. Keep reviewing the information to stay fresh. This is a recent edition with update for Quality standards.

Don't talk about it over pizza and beer with your friends on Friday night though. It probably won't help you get a date!!

3.0 out of 5 stars Good content, expensive, no index, Jan 21 2012
By Frieda "Frieda" - Published on Amazon.com
This is a mixed review. The content is good. It could be organized a little more clearly. I was, and continue to be, very disappointed that there is no index. Especially at this price point, I would expect a technical reference book to be well indexed.

Content is a good primer and reference for entry level people in the business as well as for students. The text covers a good amount of topics, but while the content that it does have is good, it is sparse on details. For example, "SOP Review and Approval" has a one paragraph description.

Pros
The content that is there is good
Good coverage of topics
Some sample documents

Cons
Price
No index
Content is sparse
Organization is so-so
› Go to Amazon.com to see all 4 reviews  4.5 out of 5 stars 

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