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

Isbn 10: 1434314685

Isbn 13: 978-1434314680

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Kitap açıklaması

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