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

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9781434348715: Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP

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

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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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Book Description AUTHORHOUSE, United States, 2008. Paperback. Book Condition: New. Language: English . Brand New Book ***** Print on Demand *****.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. Bookseller Inventory # AAV9781434348715

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Book Description AUTHORHOUSE, United States, 2008. Paperback. Book Condition: New. Language: English . Brand New Book ***** Print on Demand *****. 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. Bookseller Inventory # AAV9781434348715

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