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Devine Guidance for Complying with the FDA's Quality System Regulation is written by Christopher Joseph Devine and published by Createspace Independent Publishing Platform. It's available with International Standard Book Number or ISBN identification 1466358769 (ISBN 10) and 9781466358768 (ISBN 13).
The purpose of Dr. D's first book is to breakdown and analyze the requirements depicted in the 21 CFR, Part 820, also known as the FDA's Quality System Regulation (QSR). The doctor tackles each of the sections of the QSR sequentially and hopes the readers are able to glean some useful information while enjoying the common-sense, objective, and no-nonsense approach to complying with each of the requirements.