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Change Control for FDA Regulated Industries: A Risk Assesment Approach

Change Control for FDA Regulated Industries: A Risk Assesment Approach - Hardcover

by David N. Muchemu
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Availability:In StockContributor:David N. MuchemuPublish date:2007-10-13Pages:148
Language:EnglishPublisher:AuthorhouseISBN-13:9781434314680ISBN-10:1434314685UPC:9781434314680Book Category:Business & EconomicsBook Subcategory:Careers, ManagementSize:9.00 x 6.00 x 0.50 inchesWeight:0.8311Product ID:SCZ7PNE0CF
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
Language:EnglishPublisher:AuthorhouseISBN-13:9781434314680ISBN-10:1434314685UPC:9781434314680Book Category:Business & EconomicsBook Subcategory:Careers, ManagementSize:9.00 x 6.00 x 0.50 inchesWeight:0.8311Product ID:SCZ7PNE0CF
Publisher: Authorhouse

Contributor(s)

David N. Muchemu

Author

David N. Muchemu

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