Change Control for FDA Regulated Industries: A Risk Assesment Approach

Muchemu, David N.

ISBN 10: 1434314677 / ISBN 13: 9781434314673

Published by AuthorHouse 2007-10, 2007

About this Item

Seller Inventory # 6666-IUK-9781434314673

Bibliographic Details

• Title: Change Control for FDA Regulated Industries: A Risk Assesment Approach
• Publisher: AuthorHouse 2007-10
• Publication Date: 2007
• Language: English
• ISBN 10: 1434314677
• ISBN 13: 9781434314673
• Binding: PF
• Condition: New

About this title

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 system that meets and exceeds cGMP requirements

About the Author

Mr Muchemu is the founder,and CEO of Quality Systems International,(QSi),LLC,a consulting firm for FDA regulated industries in the capital of the Silcon Valley,(San Jose,CA).He has over twenty five years expencience in cGMP companies.He has served in different capacities in the Quality Management arena at Boston Scientific,Johnson and Johson,Genentech,American Redcross Biomedical services,Applied Biosystems and Tissue Banks international.Mr Muchemu is an advocate of profitability through compliance,and continous process improvement.