Forum: efficient CAPA management
Failure avoidance and cost reduction through efficient CAPA management
When exporting medical technology products to the USA, the requirements of the FDA (Food & Drug Aministration) must be met. One of their requirements is the use of an effective Corrective Action / Preventive Action system (CAPA).
Approximately 30% of the contested discrepencies resulting from FDA inspections can be attributed to poor implementation of CAPA systems, or to the absence of such systems.
The presentations will convey a general overview of national and international requirements, and how one can contribute to a continuing improvement of one's coporate processes. We will show how to construct, through the use of CAPA, comprehensive and integrated failure management processes and procedures, and how to efficiently and permanently structure the Improvement Processes through the aid of improvement-specific management.
Together with our partner IBS AG we will open new avenues for a structured introduction to the practical application of the integrated solution, and to the identification of opportunities for further optimization..
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