FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.
DATE: May 04, 2021 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
SUBMISSION LINK: https://register.gotowebinar.com/register/2262292866357574413
The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.
Introduction and overview
Viral clearance studies are required to assess the safety medical devices prior to commercial launch. Raw materials of animal origin, used to obtain medical devices, may contain viruses dangerous to human health. To avoid this the EU legislation as well as US FDA requirements requires manufacturers of medical devices to demonstrate the ability of manufacturing and purification processes to inactivate or remove viruses according (ISO 22442-3).
Viral clearance studies aim to evaluate the ability of the manufacturing process to inactivate/remove known viral contaminants, and to estimate process robustness by characterizing its ability to clear model viruses resembling virus that might be present in the raw material. The aim of this live webinar is to provide important insights on how to implement effective viral clearance studies to ensure the safety of medical devices for human use.
Webinar agenda
Scientific background
Regulatory requirements according to ISO 22442-3
Virus clearance steps and their efficacy:
- Selecting and testing the raw material, i.e. cell lines, tissues, organs, media components, for the absence of undesirable viruses which may be infectious and/or pathogenic for humans
- How to assess the capacity of the production processes to clear infectious viruses;
- Test setup within the production chain to verify the absence of contaminating infectious viruses
Case study
Final QA
Keynote speaker
Michele Cavalleri
GLP Facility Manager of the Biocidal Products Division in Eurofins Biolab (Italy). He has gained a solid expertise on efficay assessment of disinfectants. He is also member of the European Committee CEN TC 216 that establishes standardized methods of test and requirements for the antimicrobial efficacy of chemical disinfectants and antiseptics.
