Virus clearance of tissue-based medical devices
About the webinar
Raw materials of biological origin, used to manufacture tissue-based medical devices, may contain viral or prion agents dangerous to human health (zoonosis). EU MDR & US FDA require manufacturers of medical devices to demonstrate the ability of their processes to inactivate and/or remove such infectious particles, according to ISO 22442-3 prescriptions and 2019 FDA guidance for industry recommendations.
Topics
The following topics are some of the ones that will be touched upon in this webinar:
- Normative and regulatory overview
- Literature review according to ISO 22442-3
- Virus validation case studies
Who should attend?
Managers, directors, engineers, and scientists responsible for research and development, product development, quality assurance, and regulatory compliance. Further, procurement, business leaders, and project management personnel responsible for requesting testing quotations.
When?
June 13th 2023
15:00 - 16:00 (CET)
Where?
Speaker
Michele is Test Facility Manager (GLP and ISO 17025) for Eurofins BioPharma Product Testing Italy, for over 14 years. He is also Senior Scientific Director for virus clearance validation studies according to ISO 22442-3 & UFDA requirements as well as the virucidal efficacy of chemical & chemo-thermal processes on surfaces & equipment & virus retention procedures. Also member of the European Committee CEN TC 216.