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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