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Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration - Couverture souple

Harnack, Gordon

 
9780873898874: Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration
Couverture souple
ISBN 10 : 0873898877 ISBN 13 : 9780873898874
Editeur : ASQ Quality Press, 2014

Synopsis

The number of FDA regulations and the agency's increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm's employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions

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

Éditeur
ASQ Quality Press
Date d'édition
2014
Langue
anglais
ISBN 10 
0873898877
ISBN 13 
9780873898874
Reliure
Broché
Numéro d'édition
2
Nombre de pages
502
Coordonnées du fabricant
non disponible
Personne responsable
non disponible