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Mastering and Managing the FDA Maze, Second Edition (e-book)
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Mastering and Managing the FDA Maze, Second Edition (e-book)

Medical Device Overview

Gordon Harnack

PDF, 484 pages, Published 2014
Dimensions: 81/2 x 11
ISBN: 978-0-87389-887-4
Item Number: E1467

Member Price: $73.50

List Price: $105.00
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  • FDA
  • regulations


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