Change Control for Fda Regulated Industries: a Risk Assesment Approach - David Muchemu - Books - AuthorHouse - 9781434314673 - October 13, 2007
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David Muchemu
Change Control for Fda Regulated Industries: a Risk Assesment Approach 1st edition

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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 system that meets and exceeds cGMP requirements

Media Books     Paperback Book   (Book with soft cover and glued back)
Released October 13, 2007
ISBN13 9781434314673
Publishers AuthorHouse
Pages 148
Dimensions 9 × 152 × 229 mm   ·   226 g
Language English  

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