Investigations Operations Manual: FDA Field Inspection and Investigation Policy and Procedure Concise Reference

Investigations Operations Manual: FDA Field Inspection and Investigation Policy and Procedure Concise Reference

by Mindy J. Allport-Settle

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Overview

The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations. The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents.

The IOM is recommended reading for all operations regulated by the Food and Drug Administration.

Product Details

ISBN-13: 9780982147627
Publisher: PharmaLogika
Publication date: 01/15/2010
Pages: 800
Product dimensions: 7.00(w) x 10.00(h) x 1.59(d)
Age Range: 1 Year

About the Author

Mindy Allport-Settle has served 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, operational, project and contract management, 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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