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Change Control for Fda Regulated Industries :  A Risk Assesment Approach - David N. Muchemu

Change Control for Fda Regulated Industries

A Risk Assesment Approach

Hardcover Published: 13th October 2007
ISBN: 9781434314680
Number Of Pages: 148

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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 syst that meets and exceeds cGMP requirements

ISBN: 9781434314680
ISBN-10: 1434314685
Format: Hardcover
Language: English
Number Of Pages: 148
Published: 13th October 2007
Dimensions (cm): 23.5 x 15.88  x 1.91
Weight (kg): 0.38