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Bibliographic Details

Title: Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP
Publisher: AuthorHouse 00/r /07 A
Publication Date: 2008
Language: English
ISBN 10: 1434348717
ISBN 13: 9781434348715
Binding: Paperback
Condition: Very Good

About this title

Synopsis

This book accomplishes the following for you: 1.It helps you design a Quality management system that meets and exceeds QSR requirements. 2.It helps you understand requirements for the design of a Quality Management system for Medical Device, Pharmaceutical, Tissue, and Biomedical industries 3.It provides the Quality system document structure 4.It helps you understand Quality system requirements for ISO 13485, and ISO 9001 5.It provides standard definitions for the Quality management system 6.It gives you examples of Quality system related warning letters written by the FDA during onsite audits

About the Author

David N.Muchemu is the author of "How to Design A World-Class Corrective Action and Preventive Action System for FDA regulated industries",and "Change Control for FDA Regulated Industries".Mr Muchemu has extensive experience in Pharmaceutical,Medical Device,Biomedical,and Tissue Industries.He has worked in different capacities at Boston Scientific,Johnson and Johnson,American Redcross Biomedical services,Guidant,Advanced Bionics , Applied Biosystems and Tissue Banks International.He is the founder of QSi (LLC),a Quality Management System/cGMP consulting firm in San Jose,California.

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