FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. 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: July 6, 2023 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
SUBMISSION LINK: https://attendee.gotowebinar.com/register/2392226572059764827
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
After 10993-18 new revision issuance (2020) several questions have arisen on how general directions contained in the standard are implemented by the authorities.
This webinar aims to bridge the gap between ISO 10993-18 and authorities requirements for medical device extractables. By offering practical insights into topics such as methods qualification, AET definition, extraction conditions and others, the webinar equips participants with the knowledge and tools needed to ensure compliance with the authorities expectations.
Speaker
Enrico Franzoni is a chemist, graduated in 1997 at Università degli Studi of Milan, with more than 20 years of experience in the analytical field; after experiences in the environmental and semiconductor fields he has been working in Eurofins Biolab from 2003.
From 2003 to 2013 he was project leader of drug products GMP studies dealing mainly with extractables and leachables and method validations.
He has been Manager of Medical Devices Chemical Characterization Laboratory in Eurofins Biolab Milan since its creation in 2013, during its activity he managed a wide number of activities on all kind of medical devices.
Agenda
- Extraction: conditions, solvents selection and compatibility
- Exhaustivity: comparison between different ways to perform exhaustivity assessment
- AET calculation with focus on Uf and how to develop a Rf database
- Methods qualification
- Reference standards selection and quantification methods
- Compound Identification criteria
- Q&A
