Content
Deviations or complaints may require corrective and preventive actions (CAPA).
The seminar provides the theoretical basis for CAPA procedures for Europe and the USA and presents tried and tested methods for the correct and efficient handling of deviations within the framework of a CAPA procedure from the recording of the deviation/complaint including the interface to vigilance/reporting obligations up to the documented completion of the procedure.
Topic overview
- Legal and normative basis for CAPA processes
- Processing of deviations and complaints including interface to vigilance and reporting obligations
- Classification of deviations including risk management
- When a CAPA procedure is required
- Implementation of CAPA: correction, corrective and preventive action
- Methods of risk and cause analysis
- Documentation of a CAPA procedure
- Control of non-conforming products (separation, usage decision, risk assessment)
target group
Medical device manufacturers as well as QM managers, complaints processing, change managers, purchasing and supplier support as well as internal auditors.
Prior knowledge
Previous knowledge of quality management and the production of medical devices is recommended, but not mandatory.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
