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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:· 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.
Product Description: 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.
Title: HOW TO DESIGN A WORLD-CLASS Corrective ...
Publisher: AuthorHouse
Publication Date: 2006
Binding: paperback
Condition: Very Good
Seller: WorldofBooks, Goring-By-Sea, WS, United Kingdom
Paperback. Condition: Very Good. The book has been read, but is in excellent condition. Pages are intact and not marred by notes or highlighting. The spine remains undamaged. Seller Inventory # GOR008259743
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Paperback. Condition: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less. Seller Inventory # G1425950531I3N00
Seller: World of Books (was SecondSale), Montgomery, IL, U.S.A.
Condition: Good. Item in good condition and has highlighting/writing on text. Used texts may not contain supplemental items such as CDs, info-trac etc. Seller Inventory # 00095685691
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