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Devine Guidance for Complying with the FDA’S Quality System Regulation: 21 CFR, Part 820 Paperback – September 19, 2011
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About the Author
Dr. Christopher Joseph Devine is the President of Devine Guidance International, Inc., a consulting firm specializing in providing solutions for regulatory compliance, quality, supplier management, and supply-chain issues facing the medical device industry. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on the understanding of regulations mandated by the FDA and other regulatory bodies; and published by the Medical Device Summit, an e-magazine. Furthermore, Dr. Devine is a member of the editorial board of the Medical Device Summit. Dr. Devine has 32-years of experience in quality assurance, regulatory affairs, and program management. He is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Project Management Institute (PMI) and resides on several technical advisory boards. Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study.” Dr. Devine also holds a graduate degree in organizational management (MAOM) and an undergraduate degree business management (BSBM). Prior to launching his professional career, Dr. Devine served honorably as a United States Marine.
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I audit our suppliers to CFR 820 so if I find large gaps when auditing I recommend this book, and one other book to our suppliers.
It is organized as the QSR. For each chapter the author gives: examples of warning letters, 483 observations and then the explanation of the topic.
However, the explanations are very basic,and the suggestions repetitive (for instance, the need for SOP, this is really trivial but repeated with great enphasis for several times in each chapter, wasting a lot of space and making the reader bored). You will never find a structured approach for a topic, for instance, on how to organize a complaint management system in your company or a CAPA system. You will never find a diagram for the interaction between the different requirements.
Moreover, when you buy this book, consider that the line spacing is huge, so the effective information are much reduced.
Final remark: As said at the beginning, buy this book ONLY if new in the field, to have a general impression. Then, I suggest you to buy a more advanced book (like the AAMI compendium), which is however 20 times more expensive than this one.
I gave 3/5 stars for the price, otherwise would have been 2/5.
A suggestion to the author would be to prepare a 2nd edition.