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- Author: David N Muchemu
- Publisher: AuthorHouse
- ISBN-10: 1425950531
- ISBN-13: 9781425950538
- Format: 21 x 27.9 x 0.6 cm, minkšti viršeliai
- Language: English
- SAVE -10% with code: EXTRA
HOW TO DESIGN A WORLD-CLASS Corrective Action Preventive Action SYSTEM FOR FDA-REGULATED INDUSTRIES (e-book) (used book) | bookbook.eu
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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: Ã- Defines CAPA Ã- Provides cross-functional process flows Ã- Provides requirements for a CAPA system Ã- Provides examples for the document hierarchy needed Ã- Provides definitions for a CAPA system Ã- Provides examples of work instructions, and standard operating procedures for a CAPA system.
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- Author: David N Muchemu
- Publisher: AuthorHouse
- ISBN-10: 1425950531
- ISBN-13: 9781425950538
- Format: 21 x 27.9 x 0.6 cm, minkšti viršeliai
- Language: English English
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: Ã- Defines CAPA Ã- Provides cross-functional process flows Ã- Provides requirements for a CAPA system Ã- Provides examples for the document hierarchy needed Ã- Provides definitions for a CAPA system Ã- Provides examples of work instructions, and standard operating procedures for a CAPA system.
Reviews