Change Control for FDA Regulated Industries: A Risk Assesment Approach
Language: English
Published by Authorhouse, 2007
- Softcover
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Softcover
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- Title
- Change Control for FDA Regulated Industries: A Risk Assesment Approach
- Author
- Muchemu, David N
- Publisher
- Authorhouse
- Publication year
- 2007
- Condition
- Good
- Binding
- paperback
- Language
- English
- ISBN 10
- 1434314677
- ISBN 13
- 9781434314673
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
"Synopsis" may belong to another edition of this title.
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.
"About the title" may belong to another edition of this title.
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