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

Muchemu, David

 
9781434348715: Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP
Softcover
ISBN 10: 1434348717 ISBN 13: 9781434348715
Verlag: AuthorHouse, 2008

Inhaltsangabe

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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Über die Autorin bzw. den Autor

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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Verlag
AuthorHouse
Erscheinungsdatum
2008
Sprache
Englisch
ISBN 10 
1434348717
ISBN 13 
9781434348715
Einband
Taschenbuch
Anzahl der Seiten
132
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
KreGa Onlinehandel GmbH
4950000000000
info@krega-onlinehandel.de

Birkenweg 31
Brakel
33034
Deutschland

Weitere beliebte Ausgaben desselben Titels

9781434348722: Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements for Cgmp: Quality System Requirements (Qsr) for Cgmp

Vorgestellte Ausgabe

ISBN 10:  1434348725 ISBN 13:  9781434348722
Verlag: AuthorHouse, 2008
Hardcover