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Date: 20th - 21st May, 2008
Location: Prague, Czech Republic
Summary:Pharmaceutical - Seminar
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 year 2006, observations regarding this subject were No.2 in the ranking of cited GMP deficiencies. In the previous period, production record review deviations were observed more than any other issue.
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.
FDA’s recently published Quality System Guide and ICH Q10 also clearly emphasise the increasing relevance of a proper deviation management and CAPA.
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.
Learning Objectives:
- International Requirements - Rules and Regulations
- CAPA: principles, system, implementation and process improvements and the use of risk management techniques
- Deviation Handling and CAPA – a way to improve processes
- Deviations in the light of inspections
- OOS, OOT, OOE, OOL and a correct decision making
- Software tools for CAPA management as part of a QMS
