content
In the discussion about the terms "technical cleanliness" and "biological safety" many people get confused in the definition. If you add the keywords "hygiene" and "sterile", such discussions often do not end in a productive manner. Nevertheless, these terms are elementary and closely linked to the production of medical products, because even the most fantastic development for a medical product can become a risk for patients, users and third parties through the product due to the simplest disruptive factors in production and assembly.
The seminar provides basic information on biological safety from the point of view of quality management and regulatory affairs in order to be able to communicate effectively with test laboratories, notified bodies and other approval bodies, to identify critical points in everyday operations in good time and to present procedures, to uncover and eliminate weak points.
topic overview
- Basics of biological safety and technical cleanliness
- Overview of common measurement methods
- What does "sterile" mean?
- Biological assessment of medical devices
- Regulatory requirements, risk management and process validation
- Examples from day-to-day operations
- Procedures for identifying vulnerabilities and eliminating them
target group
Medical device manufacturers who produce themselves and/or want to know what the documentation and situation at their suppliers should look like, as well as management, those responsible for production (manufacturing & assembly), those responsible for R&D, those responsible for QM and regulatory affairs.
previous knowledge
Not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
