Content
The seminar covers the planning of cleaning processes in medical device production, including process selection, qualification and validation using practical examples. Proof of the successful cleaning of the products to notified bodies and supervisory authorities is also dealt with.
What does “free from manufacturing residues” mean? What are the requirements? What are preclinical evaluations of surfaces and the consequences for clinical evaluation?
Topic overview
- Possible residues on surfaces after manufacturing
- 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.
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
