4611021-EN
Sterilization processes for medical device manufacturers - basic course
Instructor-led Training1 DayBeginner
The seminar is focused on the essential requirements for the sterilization of medical devices and hygiene monitoring as the basis for the manufacture of sterile medical devices. You will gain a clear overview of the validation and documentation of sterilization processes in the medical device industry in order to ensure a valid manufacturing process in practice.
- Basics of microbiology
- Where do microorganisms occur and how are they transmitted?
- Procedures for microbial reduction
- Cleanrooms and their operation in accordance with the EN ISO 14644 series.
- Monitoring program for production hygiene
- Method validation
- Principles of sterilization validation according to EN ISO 14937
- You understand microbiological data and can interpret it.
- They know the hygienic requirements for the manufacture of medical devices.
- They know the requirements for the validation of sterilization processes and their documentation for medical devices.
- Manufacturers of medical devices
- Employees from controlled and clean areas
- Persons responsible for the validation of sterilization
- Persons responsible for the preparation of technical documentation
- Employees from the areas of development and quality assurance
- Product managers
This seminar is part of a modular training program. After successfully completing the modules, you can obtain this recognized qualification:
- Safety Expert Non-active Medical Devices - TÜV
The seminar deals with internationally valid standards and is also suitable for training abroad. The contents of the seminar correspond to the current state of revision/harmonization.
English
Certificate of attendance from TÜV SÜD Academy