content
The seminar covers the planning of the cleaning processes in the manufacture of medical devices, including the selection of processes, qualification and validation using practical examples. Evidence of the successful cleaning of the products for notified bodies and supervisory authorities is also dealt with. What does "free of manufacturing residues" mean? What are the requirements? What are preclinical surface evaluations and the implications for clinical evaluation?
topic overview
- Possible residues on surfaces after manufacture
- Qualification and validation of cleaning processes including method descriptions and re-validations
- Cleaning procedures and validation of these procedures
- Characterization of cleaned surfaces including verification
target group
Medical device manufacturers, QM managers, regulatory affairs, validation teams, design transfer teams and production managers for cleaning processes.
previous knowledge
Recommended in quality management and in the manufacture of medical devices, but not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
