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Change Control for FDA Regulated Industries: A Risk Assesment Approach indir

Isbn 10: 1434314685

Isbn 13: 978-1434314680

Change Control for FDA Regulated Industries: A Risk Assesment Approach indir kitap bedava

itibaren David N. Muchemu

yayınevi AuthorHouse

dil İngilizce

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Change Control for FDA Regulated Industries: A Risk Assesment Approach

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

yazar:David N. Muchemu

Isbn 10:1434314685

Isbn 13:978-1434314680

yayınevi:AuthorHouse

dil:İngilizce

Boyutlar ve boyutlar:15.24 x 1.27 x 22.86 cm

Tarafından gönderildi
Change Control for FDA Regulated Industries: A Risk Assesment Approach:13 Ekim 2007

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