Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements for Cgmp - Couverture rigide

Muchemu, David N.

Couverture rigide

ISBN 10 : 1434348725 ISBN 13 : 9781434348722

Editeur : AuthorHouse, 2008

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

A propos du livre

Présentation de l'éditeur

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

Biographie de l'auteur

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.

Détails de l'édition

• Éditeur: AuthorHouse
• Date d'édition: 2008
• Langue: anglais
• ISBN 10: 1434348725
• ISBN 13: 9781434348722
• Reliure: Relié
• Nombre de pages: 132
• Coordonnées du fabricant: non disponible
• Personne responsable: KreGa Onlinehandel GmbH; 4950000000000; info@krega-onlinehandel.de; ; Birkenweg 31; Brakel; 33034; Allemagne