Content
Non-verifiable processes in the production of medical devices must be validated. This is required by both DIN EN ISO 13485 and the FDA specification. For example, there are specific instructions for validation for sterilization or packaging processes of products. The instructions for validating the other manufacturing processes are not described in the regulations. This includes, among other things, soldering, gluing, coating and washing. Consequently, the manufacturer must develop the appropriate method and the corresponding evidence as well as the documentation for validation itself.
The seminar provides background information, models and practical tips for process validation.
Topic overview
- Relevant specifications such as standards and guidelines for validating processes
- Model of a process validation, explanation and procedure for the stages of validation:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Explanations for implementation using practical examples
- Regulation of responsibility for outsourced processes requiring validation
target group
QM representatives, employees from the quality assurance department, those responsible for production and development from companies in the medical device industry and their supply industry.
Prior knowledge
Beginner seminar, but previous knowledge of DIN EN ISO 13485 is recommended.
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
