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
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"
Available downloads:
Reading Sample "How to Manage Corrective and Preventive Actions (CAPA) in GMP Environment"
Technical Requirements
This file is in PDF format!
Filesize: 864 KB
To view PDF files, we recommend using the Adobe Reader.
https://get.adobe.com/de/reader/
The e-book is password protected to prevent copying and modification of content.
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€87.00 net
€87.00 net
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