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Quality Management

Implementing a World Class Deviation Management
€ 87.00
€ 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.
pdf download
Excerpt from the GMP Compliance Adviser
Edition: first edition, 12/2015
28 Pages
ISBN: 978-3-95807-030-1
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

In spite of qualified equipment, trained employees and validated processes, the daily routine in pharmaceuticals is rife with situations in which prescribed workflows are not observed or processes fail to deliver the expected results. For this reason it is important not only to define the workflows for production in "normal cases", but also to specify how such deviations are to be handled. This will ensure that acceptable product quality can be obtained even in the event of unforeseen circumstances.

You will learn all you need to know about
  • Requirements for deviation management
  • Workflow of deviation management
  • Responsibilities
  • Failure investigation report
  • Evaluations
  • Review of the system effectiveness
  • Interfaces to the CAPA system
  • Examples
  • Quotes from regulatory works
Order now your copy of Implementing a World Class Deviation Management!

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Gausepohl, Dr. Christian

Gausepohl is Head of the Quality Unit and a Qualified Person at Rottendorf Pharma. He has worked in many different positions and has extensive experience of carrying out audits and inspections for authorities, customers and suppliers. His main concern is the practical implementation of GMP requirements.

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How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment
Managing Outsourced GMP Activities Successfully