Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP - Softcover

Muchemu, David

Softcover

ISBN 10: 1434348717 ISBN 13: 9781434348715

Publisher: AuthorHouse, 2008

Synopsis

Having a robust and functional Quality Management system is a QSR requirement for all Pharmaceutical,Biomedical,and Medical Device companies.This book does the following for you:1.It helps Managers in Startup companies 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 industries3.It provides the Quality system document structure4.It helps you understand Quality system requirements for ISO 13485,and ISO 90015.It provides standard definitions for the Quality management system6.It provides examples of Quality system related warning letters written by the FDA during onsite audits7.It provides the reader several models of a Quality Management system

About this title

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.

Edition details

• Publisher: AuthorHouse
• Publication date: 2008
• Language: English
• ISBN 10: 1434348717
• ISBN 13: 9781434348715
• Binding: Paperback
• Number of pages: 132