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
- 25th May 2012- SETO01/05/12 (new date)
- 27th November 2012 - SETO01/11/12
Course Outline
This highly interactive course is designed for those seeking an in depth perspective of the Ethylene Oxide Sterilization process. It covers the practical aspects of the process and the detailed regulatory requirements necessary to achieve compliance to the three Medical Device Directives, ISO 11135 series and ISO 10993-7. Speakers include High Edge Consulting sterilization experts, BSI Sterilization expert and Isotron, the leaders in contract sterilization.
The course will give participants practical and real examples of the issues, such as sterilization validation, deviation disposition & investigation, residuals decay dynamics and packaging considerations. We look at the whole process from the earliest design stages to routine production.
In addition you will cover particular challenges to ethylene oxide sterilization including validation and routine control of your products. To enhance the learning we will use sample medical devices to work with and assess, which will assist with demonstrating best practice principles in relation to regulatory requirements. We encourage you to bring samples of your products along for inclusion in the debate and discussions. The discussions are confidential. By using real life samples you will gain more from the course.
Whilst sterilization is the end goal, there are other considerations to consider. We will consider microbiological control of pre-sterilization product bioburden, post-sterilization endotoxin and post-sterilization residuals and the regulatory framework in order to help you achieve compliance.
This is an advanced course aimed at senior technical, regulatory, design and quality practitioners. Previous familiarity with the Ethylene Oxide process is desirable but not essential. We use our own microbiology & 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 include
- Background to single-use medical devices
- Detailed explanation of the EtO process
- Microbiological aspects of EtO Sterilization
- Regulatory requirements of ISO 11135-1 and ISO/TS 11135-2
- Process validation—different approaches & how the process is validated
- Management of routine sterilization cycles, product release and process deviations
- Ethylene oxide residuals (ISO 10993-7)
Outcomes
At the end of the seminar, delegates will gain an insight into:
- The EtO sterilization process
- The regulatory requirements for the EtO process
- EtO sterilization validation
- EtO sterilization routine control
- Release criteria for the EtO 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
