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portada how to design a world-class corrective action preventive action system for fda-regulated industries: a handbook for quality engineers and quality mana
Type
Physical Book
Author
Publisher
Year
2006
Language
English
Pages
104
Format
Paperback
Dimensions
27.9 x 21.0 x 0.6 cm
Weight
0.25 kg.
ISBN
1425950531
ISBN13
9781425950538

how to design a world-class corrective action preventive action system for fda-regulated industries: a handbook for quality engineers and quality mana

David N. Muchemu (Author) · Authorhouse · Paperback

how to design a world-class corrective action preventive action system for fda-regulated industries: a handbook for quality engineers and quality mana - Muchemu, David N.

New Book Imported to Austria
Delivery: 07 Aug - 11 Aug Shipping: 4 to 5 business days.
28,13 €
Import costs and 10% VAT included in the price ✅
28,13 €

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Synopsis "how to design a world-class corrective action preventive action system for fda-regulated industries: a handbook for quality engineers and quality mana"

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: Â- Defines CAPA Â- Provides cross-functional process flows Â- Provides requirements for a CAPA system Â- Provides examples for the document hierarchy needed Â- Provides definitions for a CAPA system Â- Provides examples of work instructions, and standard operating procedures for a CAPA system.

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