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: June 13, 2023 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
SUBMISSION LINK: https://attendee.gotowebinar.com/register/1421744832096373595
ATTENDEES CAPACITY: 500 delegates
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
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 as well as US FDA require manufacturers of medical devices to demonstrate the ability of their manufacturing processes to inactivate and/or remove such infectious particles, according to ISO 22442-3 prescriptions and 2019 FDA guidance for industry recommendations.
A comprehensive documental assessment and a robust experimental design are needed in order to clearly identify zoonosis risk and the potential virus clearance steps in the manufacturing process under investigation.
The aim of this live webinar is to provide important insights on how to identify and validate viral clearance steps by means of diverse case studies in order to ensure the safety of tissue-based in a robust way and in compliance to the current EU and US requirements.
Agenda
- Normative and regulatory overview
- Literature review according to ISO 22442-3: similarity, equivalence and weighted assessment
- Virus validation studies:
- Case study 1: lab-scale validation of worst case approach in a thermal step: steep gradients and short times
- Case study 2: lab-scale validation of a worst case approach from very large to small scale
- Case study 3: homogeneous virus spike and exhaustive recovery – how far?
- Case study 4: process controls in a multi-site study
Speaker
Michele Cavalleri has a solid background as GLP and ISO 17025 Test Facility Manager within Eurofins BioPharma Product Testing Italy for over 14 years.
From a technical point of view, he has gained a strong and reliable expertise, first as a validation manager and afterwards as Senior Scientific Director within the Eurofins BPT Italy, on virus clearance validation studies according to ISO 22442-3 and UFDA requirements as well as the virucidal efficacy of chemical and chemo-thermal processes on surfaces and equipment as well as virus retention procedures for the biopharmaceutical sites. He is also member of the European Committee CEN TC 216 that establishes standardized methods of test and requirements for the disinfectant and virucidal efficacy of chemical disinfectants and antiseptics.
