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Quality Management

How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment
€ 87.00
net
€ 103.53
Der MwSt.-Satz richtet sich nach der Produktart, auf Print-Produkte werden 7% und auf digitale Produkte 19% berechnet. Bei Bundle-Produkten werden beide Steuersätze berücksichtigt. Vor dem endgültigen Auslösen der Bestellung wird die MwSt. bestellspezifisch angezeigt.
US$
99.00
pdf download
Excerpt from the GMP Compliance Adviser
Edition: First edition, 09/2015
24 Pages
ISBN: 978-3-95807-16-5
Delivery: immediately after receipt of payment
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 pdf download 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"
Get started now. Order your copy of How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment.

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Filesize: 864 KB

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Renger, Dr. Bernd

Bernd Renger has been working as a freelance consultant since 2011. He specialises in the development of efficient quality assurance systems, the preparation and follow-up of inspection, the establishment of effective deviation management and the design of sterile and aseptic processes. He works as a lecturer at the University of Sigmaringen and is the co-founder of the European QP Association.

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GMP Compliance Adviser
Single User Licence (monthly subscription)
Pharma Change Control
GMP Fundamentals – A Step-by-Step Guide (book)