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

Author: David N. Muchemu
Publisher: Authorhouse
Published: 10/13/2007
Pages: 148
Binding Type: Hardcover
Weight: 0.83lbs
Size: 9.00h x 6.00w x 0.50d
ISBN: 9781434314680

This title is not returnable