CHANGE CONTROL FOR FDA REGULATED INDUSTRIES: A RISK ASSESMENT APPROACH

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9781434314673: CHANGE CONTROL FOR FDA REGULATED INDUSTRIES: A RISK ASSESMENT APPROACH
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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

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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.

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9781434314680: Change Control for FDA Regulated Industries: A Risk Assesment Approach

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Book Description AUTHORHOUSE, United States, 2007. Paperback. Condition: New. Language: English . Brand New Book ***** Print on Demand *****.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. Seller Inventory # AAV9781434314673

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Book Description AUTHORHOUSE, United States, 2007. Paperback. Condition: New. Language: English . Brand New Book ***** Print on Demand *****. 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. Seller Inventory # AAV9781434314673

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Book Description AUTHORHOUSE, United States, 2007. Paperback. Condition: New. Language: English . This book usually ship within 10-15 business days and we will endeavor to dispatch orders quicker than this where possible. Brand New Book. 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. Seller Inventory # LIE9781434314673

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Book Description AuthorHouse. Paperback. Condition: New. 148 pages. Dimensions: 8.8in. x 5.9in. x 0.5in.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 costbenefit analysis. Helps the reader design a Change control system that meets and exceeds cGMP requirements This item ships from multiple locations. Your book may arrive from Roseburg,OR, La Vergne,TN. Paperback. Seller Inventory # 9781434314673

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