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Deviations or customer complaints may require corrective and preventive actions (CAPA). The seminar conveys the theoretical basics for CAPA procedures for Europe and the USA and presents tried-and-tested methods for the correct and efficient handling of deviations within the scope of a CAPA procedure, from the recording of the complaint/deviation to the documented completion of the procedure.
topic overview
- Legal and normative bases for CAPA processes
- Processing of deviations and customer complaints
- Classification of deviations including risk management
- When is a CAPA procedure required
- Execution of CAPA: corrective, corrective and preventive action
- Methods of risk and cause analysis
- Documentation of a CAPA procedure
- Control of non-compliant products (separation, usage decision, risk assessment)
target group
Medical device manufacturers as well as QM managers, complaints processing, change managers, purchasing and supplier support and internal auditors.
previous knowledge
Prior knowledge of quality management and the manufacture of medical devices is recommended, but not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
