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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
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.
104 pages, Kindle Edition
First published August 17, 2006
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May 30, 2013
The overall objectives were well stated and linked to entire QMS system considerations. Highlights the importance of this being proactive and preventative versus reactive. There is a lot of detail in the examples that might be overkill, however as a reference tool, the various matrices and vocabulary sections are good.
The management information system requirements are intensive since this is written for FDA-regulated organizations, but the basic guidelines are a good framework to follow.
The management information system requirements are intensive since this is written for FDA-regulated organizations, but the basic guidelines are a good framework to follow.
Displaying 1 of 1 review