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How To Design A World-class Corrective Action Preventive Action System For Fda-regulated Industries
A Handbook For Quality Engineers And Quality Managers
- Editore:
Authorhouse
- EAN:
9781425950538
- ISBN:
1425950531
- Pagine:
- 104
- Formato:
- Paperback
- Lingua:
- Inglese
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Descrizione How To Design A World-class Corrective Action Preventive Action System For Fda-regulated Industries
The CAPA (Corrective Action/Preventive Action) Quality subsystem is the most audited by FDA inspectors. This book is designed to help Quality management professionals in Biomedical, Pharmaceutical, Tissue, and Medical Device industries design a CAPA Quality subsystem that meets and exceeds CAPA requirements in 21CFR 820.100(J).This book accomplishes the following: Defines CAPA Provides cross-functional process flows Provides requirements for a CAPA system Provides examples for the document hierarchy needed Provides definitions for a CAPA system Provides examples of work instructions, and standard operating procedures for a CAPA system.
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