Sterilization Validation and Cleaning Validation
- Manufacturers of finished medical devices should provide clear, understandable and reproducible cleaning and sterilization protocols that have been validated to be effective. Due to the development of more complex devices, the biggest challenge for reusable medical devices is an appropriate design process not only to facilitate the use of the device, but to facilitate the eventual reuse through an adequate cleaning and disinfection/sterilization process.Many medical devices need to be able to function safely after hundreds of cleaning and disinfection or sterilization cycles.A thorough understanding of device cleaning, disinfection, and sterilization issues is therefore essential in the design phase of any reusable medical device.This conference will provide a wide and comprehensive overview of critical aspects of cleaning and sterilization validation of Medical devices.
This conference offers a rewarding experience and is particularly relevant to those directly involved or supporting the development of cleaning/sterilization validation programs and plans, also those responsible for cleaning validation protocols and execution activities. This includes validation, engineering, operations, consultants also Quality Control and Quality Assurance personnel.
- 9.00 – 9.30: Registration
- 9.30 – 10.30: ETO Sterilization of Medical Devices Harry Leinwand (M.Sc, CQE, Managing Director, R&Q Consulting Ltd)
- 10:30-10:45: Coffee break and refreshments
- 10:45 – 12:45: Cleaning & reprocessing validation Paolo Pescio (Eurofins Medical Device Testing Italy)
- 12:45 – 13:45: Lunch
- 13:45- 14:45: Endotoxin contamination after sterilization: FDA expectation Paolo Pescio (Eurofins Medical Device Testing Italy)
- 14:45 – 15:00: Coffee break
- 15:00-15:30: ISO 10993-7: Ethylene Oxide Sterilization Residuals Sally Bercovich (Li-Med)
- 15:30-16:00: Q & A session
- 16:00-17:30: One on One Personal meetings
Paolo Pescio
With more than 10 years of experience performing pre-clinical evaluation for medical devices earned a M.S. in Biomedical Engineering from Polytechnic University of Milan (Italy). Former
Chairman of the UNI U4201 Committee for non-active medical devices for transfusion and biological evaluation is an active member of ISO TC194 and CEN TC206 groups. He also has a successful background as Test Facility Manager, and his expertise lies in: Toxicological evaluation and risk assessment Biological evaluation of medical devices Integrated Testing Strategies Validation of sterilization process E&L assessment PDE evaluation.
Harry Leinwand
An expert in Quality Systems, Sterilization and Regulatory Affairs for companies in the medical device industry. For nearly 30 years Harry has been focusing on preparation and implementation
of QA systems compliant with the international standard ISO 13485, the EC Directives and Regulations, Canadian Medical Device Regulations and the FDA Quality System Regulations, as well as in controlled environments & sterilization processes. In the field of sterilization, Harry has helped medical device companies by preparing protocols and reports for aseptic processing and steam, EtO and Gamma irradiation terminal sterilization processes according to consensus/ harmonized standards. On top of that, he assisted in sterilization validation files and preparation of expert reports for DEKRA Certification B.V, The Netherlands.
Sally Bercovich
Sally is QA\RA expert with more than 12 years of experience. She has vast experience in leading quality processes and regulatory projects for companies in the field of medical devices and agriculture. Her main expertise’ are sterilization validation and biocompatibility. Sally’s strongest suit is her broad understanding of processes and her ability to drill down to the smallest detail.