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

by David N. Muchemu

2021-01-05 06:14:34

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, Pharmace... Read more
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 Less

Book Details

File size9 X 6 X 0.31 in
Print pages132
PublisherAuthorhouse
Publication date April 5, 2008
LanguageEnglish
ISBN9781434348715

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