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Deviation Management and CAPA
1-2 June 2010
Berlin, Germany
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Learning Objectives
During this course, you will learn all relevant aspects to implement and/ or improve your Deviation Management and CAPA System which fulfils regulatory GMP requirements. Furthermore, you will get to know possibilities and tools to successfully investigate failures and OOS results.
Background
FDA’s Quality System Guide and ICH Q10 clearly emphasise the increasing relevance of a proper deviation management and CAPA.
As indicated in ECA’s Warning Letter Report, production record review is one of the most frequent GMP deviations observed by the FDA. In the fiscal years 2008, 2007 and 2005, observations regarding this subject were No. 1 in the ranking of cited GMP deficiencies. After a closer look at these citations, it becomes obvious that most observations are caused by failures in deviation management and CAPA. In most cases, deviations were noticed by the pharmaceutical company but no sound investigation was performed and no consequences were defined.
But also OOS results are deviations and need to be thoroughly investigated as well as OOT and OOE results.
Independent from that, it needs to be pointed out that CAPA is an excellent Quality Management Tool to continuously improve your processes and avoid future failures. |
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