Content
Clean rooms for the production of medical devices are among the environmental conditions that require control. Among other things, DIN EN ISO 13485 requires the validation of environmental conditions that require control in medical technology. ISO 14644 offers an internationally recognized standard for clean rooms.
The seminar provides an overview of the necessary validation activities for clean rooms and other environments requiring control based on the above-mentioned standards. This addresses which test procedures should be used in which phases of validation. It also highlights how the validation strategy can be created on a risk-based basis. The focus is on practical and audit-proof planning and documentation of cleanroom validation.
Topic overview
- Basics of regulatory requirements (including ISO 14644)
- Basics on, among other things, clean room classes, germ measurements and environmental conditions that require control
- Risk-based validation strategy
- Test procedures within cleanroom validation
- Validation content and documentation within IQ, OQ and PQ
- Practical applications
target group
Employees from the areas of QM/QS, microbiology and hygiene, production managers, process and validation engineers, PRRC and other interested parties.
Prior knowledge
No specific validation knowledge is required.
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:
Online
