This seminar will provide you with practice-focused interpretation and guidance for the EN ISO 11607-1:2014, EN ISO 11607-2:2014 standards and their requirements concerning the validation of sterile packaging design and processes for terminally sterilised medical devices. The implementation of this standard poses a challenge to many medical device manufacturers. The seminar will provide you with a basic overview of the key content of the standard and the requirements it imposes on the validation of packaging processes.
- Terms and definitions
- Requirements of EN ISO 11607-1:2014
- Basic requirements for sterile packaging
- Basics of the packaging process
- Basic requirements of Directive 93/42/EEC on sterile packaging
- Decision-making criteria for the selection of packaging materials
- Test method for packaging materials
- Validation of the packaging processes (OQ/PQ) according to EN ISO 11607-2:2014
- Transport validation
Who should attend
- Manufacturers and designers of medical devices
- Designers and developers
- Product managers
- Project leaders
- Personnel in quality management
- Personnel in regulatory affairs
Certificate of attendance issued by TÜV SÜD Akademie
The seminar content corresponds to the present status of the revised/harmonised standard.
TÜV SÜD Akademie senior expert
- You acquire profound knowledge of the requirements for sterile packaging according to EN ISO 11607.
- You obtain practical know-how on the validation of your packaging processes.
- You can ensure sterile packaging of your medical devices.