CAPA for the FDA-regulated Industry

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ASQ Quality Press, 2011 - Business & Economics - 147 pages
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Contents

Chapter 1The Quality System and CAPA
1
Chapter 2CAPA and the Life Sciences Regulated Industry
9
From Problem Detection to Effectiveness Check
31
Chapter 4Documenting CAPA
89
Chapter 5The Ten Biggest Opportunities of the CAPA System and How to Fix Them
93
Chapter 6Developing an Internal CAPA Expert Certification
105
Chapter 7CAPA Forms
113
Chapter 8CAPA Final Recommendations
125
Appendix A
127
Acronyms
129
Glossary
131
Bibliography
137
Index
141
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