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Book synopsis

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

Book details

Book category Books in English Health & personal development Self-help & personal development Advice on careers & achieving success

• Full title: Change Control for Fda Regulated Industries
• Subtitle: A Risk Assesment Approach
• Author: David N Muchemu
• Language: English
• Binding: Hardback
• Number of pages: 148
• EAN: 9781434314680
• ISBN: 9781434314680
• ID: 08493299
• Publisher: AuthorHouse
• Weight: 398 g
• Dimensions: 237 × 161 × 18 mm
• Date of publishing: 13. October 2007

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