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

Devine PhD, Dr. Christopher Joseph

 
9781466358768: Devine Guidance for Complying with the FDA’S Quality System Regulation: 21 CFR, Part 820
Couverture souple
ISBN 10 : 1466358769 ISBN 13 : 9781466358768
Editeur : CreateSpace Independent Publishing Platform, 2011

Synopsis

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.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

À propos de l'auteur

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.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
CreateSpace Independent Publishing Platform
Date d'édition
2011
Langue
anglais
ISBN 10 
1466358769
ISBN 13 
9781466358768
Reliure
Broché
Nombre de pages
256
Coordonnées du fabricant
Manufactured by Amazon on behalf of the author
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