target group

QM officers, employees from the quality assurance department, those responsible for production and development from companies in the medical device industry and their suppliers.

content

Non-verifiable processes involved in the manufacture 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 on validation for the sterilization or packaging processes of products. The instructions for validating the other manufacturing processes are not described in the regulations. These include soldering, gluing, coating and washing. Consequently, the manufacturer has to develop the appropriate method and the corresponding proof as well as the documentation for the validation himself.

topic overview

The seminar provides background information, models and practical tips for process validation. In addition, the following content will be discussed:

  • Relevant specifications such as standards and guidelines for the validation of processes
  • Process validation model, 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 that require validation

previous knowledge

beginner seminar; However, prior knowledge of DIN EN ISO 13485 is recommended.

KONTAKT:
Max-Planck-Straße 17,  Tuttlingen
Beruflichen Bildungsstätte Tuttlingen & Online

 

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