FDA Establishment Inspections: Pharmaceutical, Biotechnology, Medical Device and Food Manufacturing Concise Reference

FDA Establishment Inspections: Pharmaceutical, Biotechnology, Medical Device and Food Manufacturing Concise Reference

by Mindy J. Allport-Settle
     
 

Establishment Inspections, Chapter 5 of the FDA's Investigations Operations Manual, details every step FDA inspectors are required to follow when conducting a facility inspection. This text is a comprehensive reference for regulatory inspections and is useful as an introduction to the practical components of the FDA-regulated industries or as a…  See more details below

Overview

Establishment Inspections, Chapter 5 of the FDA's Investigations Operations Manual, details every step FDA inspectors are required to follow when conducting a facility inspection. This text is a comprehensive reference for regulatory inspections and is useful as an introduction to the practical components of the FDA-regulated industries or as a refresher.

While the specific regulations and requirements may differ widely between pharmaceutical, biotechnology, medical device, and food manufacturers, the inspection processes and procedures do not.

Product Details

ISBN-13:
2940012094032
Publisher:
PharmaLogika
Publication date:
07/06/2010
Sold by:
Barnes & Noble
Format:
NOOK Book
Pages:
356
File size:
805 KB

Meet the Author

Following in the footsteps of Gordon Allport, all of Mindy J. Allport-Settle's books are built on a foundation of psychology and sociology with a focus on improving some aspect of industry through research and education.

Her career in healthcare began when she was a teenager working as an emergency medical technician. Since then, she has joined the U.S. Navy's advanced hospital corps, worked in organ and human tissue procurement, specialized in ophthalmology, and moved on to serve as a key executive, board member, and consultant for some of the best companies in the pharmaceutical, medical device, and biotechnology industry. She has provided guidance in regulatory compliance, corporate structuring, restructuring and turnarounds, new drug submissions, research and development and product commercialization strategies, and new business development. Her experience and dedication have resulted in international recognition as the developer of the only FDA-recognized and benchmarked quality systems training and development business methodology.

Her education includes a Bachelor's degree from the University of North Carolina, an MBA in Global Management from the University of Phoenix, and completion of the corporate governance course series in audit committees, compensation committees, and board effectiveness at Harvard Business School.

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