Who should attend
This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:
- Members of the senior management team
- Regulatory Affairs managers
- Regulatory Affairs officers
- Quality Assurance professionals
- Quality Assurance officers
- Development engineers
- Operations managers
- Packaging engineers
Book onto this course
- 3rd July 2012 - SGAM01/07/12
- TBC January 2012
Course Outline
This engaging and interactive course is designed for those individuals with an interest in the irradiation process and are looking to deepen their knowledge. It covers the practical aspects of the process and the detailed regulatory requirements necessary to achieve compliance to the three Medical Device Directives and ISO 11137 series.
Irradiating products, using gamma or electron beam, impacts on all aspects of medical device design, manufacture and packaging. We will look at polymer and material selection, implications for packaging and any potential long term impacts post treatment using sample medical devices. We encourage you to bring samples of your products along for inclusion in the confidential debate and discussions.
The course will give participants practical and real examples of the issues surrounding process validation and the various methods for sterilization validation. The course will cover in detail method 1 studies, method 2 studies and VDmax methodology as well as requirements for product bioburden testing.
The course is hosted by our own microbiology and sterilization experts, along with guest speakers from Isotron, Europe’s foremost contract sterilization specialists. This course is strictly limited to a maximum of just 10 participants to ensure each delegate maximises their learning.
Topics covered
- Background to single-use medical devices
- Detailed explanation of the irradiation process
- Detailed explanation of irradiation sterilization
- Insights into ISO 11137-1, ISO 11137-2 & ISO 11137-3
- The regulatory framework within which the process operates
- Process validation – different approaches and how the process is validated
- Possible issues with the use of irradiation
Course outcomes
At the end of the seminar, delegates will gain an insight into:
- Medical device sterilization
- The irradiation process – gamma and electron beam
- The impacts of the process on the device
- The various regulatory requirements for the process
- Release criteria for the process
Venue
- Holiday Inn, Birmingham, UK
- Close to Birmingham International Airport & International train station (with free shuttle bus)
- 1 minute from junction 6 of the M42
