FDA Worldwide Quality Requirements
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Book Overview
This guidebook provides essential informantion for anyone who needs to understand and implement the new U.S. Food and Drug Administration (FDA) law for medical devices and international quality system... This description may be from another edition of this product.
Format:Hardcover
Language:English
ISBN:0873893778
ISBN13:9780873893770
Release Date:January 1996
Publisher:ASQ Quality Press
Length:210 Pages
Weight:1.20 lbs.
Customer Reviews
1 rating
Good at laying out the rules
Published by Thriftbooks.com User , 24 years ago
Mfg. Engr. manager for a large medical device company. After spending 2.5 days with an FDA auditor, I realized that I did not know what was expected by the regulatory body in terms of process validations, equipment installation and maintenance and all of the record-keeping and documentation that is required for them.To learn all of that quickly, I purchased and studied this book. For each subject (process validations, equipment, calibration and all other areas), it lists the FDA regulation, the corresponding ISO regulation and then has an "FDA guidance" section that breaks down both into plainer English. It was helpful to have all of the information in one place.The frustrating part with the FDA is that they won't tell you exactly how to do things, they'll just lay out the rules and you have to figure out how to get there from here. This book is good at laying out all of the rules. I would recommend this book to any level person who may have to answer to an auditor. There are sections on Design Control, Nonconforming Production, Labeling and Packaging, Statistical Techniques and more that apply to each area of the business.
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