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FDA Maze |
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"Mastering and Managing the FDA Maze: Medical Device
Overview." written by Gordon Harnack, our managing
Consultant, is published by the American Society for
Quality's Quality Press (April 1999). 20 chapters,
40+ figures and almost 300 pages.
The book was written for:
- Regulatory professionals, who know their responsibility
to keep their firm's employees trained and competent on
FDA device regulations and require a preliminary desk
reference that can be used throughout their enterprise to
help train and ensure compliance.
- Neophytes, who know nothing about FDA and 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 have a reference tool to be effective and
productive in their job
- Intermediates, who know enough about the FDA to know
they need to know more and need a reference tool that
provides them both basics and executable detail.
- Busy Managers, who need to know regulatory
requirements and FDA expections in order to manage
compliance in their specific activity.
- Busy Exectivies, (CEO's, COO's and operations
managers - whom FDA holds responsible for all regulatory
compliance) that need a desk reference with specific
information to quickly assess requlatory compliance, identify
noncompliance and review corrective, preventive and
compliance.
CLICK HERE TO REVIEW BOOK'S TABLE OF CONTENTS!
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