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How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment

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This e-book shows how you can establish an effective CAPA system, which interfaces there are to other systems and what content a CAPA SOP should have.

e-book

24 pages

ISBN: 978-3-95807-16-5

1st edition 2015

Delivery immediately after receipt of payment

€87.00 net

€91.35 * prices incl. VAT

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Excerpt from the GMP Compliance Adviser

Inadequate CAPA procedures continue to be among the leading findings in U.S. FDA and European GMP inspections. During the implementation of a CAPA system it should be ensured that the CAPA system is understood as an important element of the pharmaceutical quality system and, consequently, that it is implemented uniformly company-wide or group-wide, as a governing system.

How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment is the ultimate guide on building and implementing an effective CAPA compliance program. The e-book shows how you can establish an effective CAPA system, which interfaces there are to other systems and what content a CAPA SOP should have.

Here’s an overview of what you’ll discover in its pages:

Regulatory background
Definitions
Organizational Integration
Documentation and tracking
Efficacy and sustainability
Efficient implementation
Sample SOP "CAPA System"

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This file is in PDF format!
Filesize: 864 KB

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The e-book is password protected to prevent copying and modification of content.

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