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

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AuthorHouse, Apr 7, 2008 - Business & Economics - 132 pages
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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 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 provides examples of Quality system related warning letters written by the FDA during onsite audits

7.It provides the reader several models of a Quality Management system

 

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Contents

CHAPTER ONE
1
CHAPTER TWO
19
CHAPTER FOUR
29
CHAPTER SIX
53
CHAPTER SEVEN
63
CHAPTER EIGHT
71
CHAPTER NINE
79
CHAPTER TEN
87
CHAPTER ELEVEN
103
Appendix A
109
Appendix B
115
Back Cover
121
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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 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 provides examples of Quality system related warning letters written by the FDA during onsite audits

7.It provides the reader several models of a Quality Management system

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