Devine Guidance for Complying with the FDA’S Quality System Regulation: 21 CFR, Part 820

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9781466358768: Devine Guidance for Complying with the FDA’S Quality System Regulation: 21 CFR, Part 820

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.

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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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Book Description Createspace, United States, 2011. Paperback. Book Condition: New. Language: English . Brand New Book ***** Print on Demand *****.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. Bookseller Inventory # APC9781466358768

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Book Description Createspace, United States, 2011. Paperback. Book Condition: New. Language: English . Brand New Book ***** Print on Demand *****. 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. Bookseller Inventory # APC9781466358768

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Book Description Createspace. Paperback. Book Condition: New. This item is printed on demand. Paperback. 233 pages. The purpose of Dr. Ds first book (Devine Guidance for Complying with the FDAs Quality System Regulation) is to breakdown and analyze the requirements depicted in the 21 CFR, Part 820. The doctor tackles each of the subparts and sections 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. In support of providing a better understanding for what the agency is searching for by the way of compliance, each chapter of the book is supported by excerpts of warning letters extracted from the FDAs website. For those of you that are frequent followers of Dr. Ds weekly rants, posted in The Medical Device Summit, you will recognize the often poignant prose employed by Dr. D. Now granted, the topics of regulatory and quality compliance can be extremely boring to write about; however, the doctor has taken some liberties in an effort to ensure reader boredom does not occur. That being said, Dr. D really hopes you enjoy this book! This item ships from La Vergne,TN. Paperback. Bookseller Inventory # 9781466358768

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