Why should I join the webinar?
In this webinar, we will:
- Learn what are the critical parameters of EO sterilization process and what impact they will have on your product safety and performance
- Go through a detailed checklist that will help you to make the right decisions before you start any EO sterilization validation activities
- Learn where (and when) it is possible to save time and effort required to validate your medical device according to ISO 11135 and other applicable standards
*At the end of the webinar we will have a quick Q&A session to address your main concerns.
Who should attend?
- Company or department managers in the medical device field
- Regulatory affairs and QA experts
- R&D and and V&V managers
- Experts involved in the evaluation of Medical Devices and QMS
Sally Bercovich – EO Sterilization Expert, with extensive experience and broad knowledge in different aspects in EO sterilization of medical devices, such as: EO sterilization validations and re-validations, single batch release, change impact assessment, product adoption into validated EO sterilization process risk assessments following re-qualification failure, laboratory testing strategy (microbiology/EO residuals).