Change Control for FDA Regulated Industries

Download or Read eBook Change Control for FDA Regulated Industries PDF written by David N. Muchemu and published by AuthorHouse. This book was released on 2007 with total page 150 pages. Available in PDF, EPUB and Kindle.

Author	: David N. Muchemu
Publisher	: AuthorHouse
Total Pages	: 150
Release	: 2007
ISBN-10	: 9781434314680
ISBN-13	: 1434314685
Rating	: 4/5 (80 Downloads)

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Book Synopsis Change Control for FDA Regulated Industries by : David N. Muchemu

Book excerpt: This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Defines the different phases of the change control life cycle .Establishes the relationship between risk management, cost of doing business and change control .Defines regulatory requirements for change control, including requirements for (510k) submission .Provides tools for risk assesment, and cost/benefit analysis .Helps the reader design a Change control system that meets and exceeds cGMP requirements

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