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Formazione >> Webinar e Formazione Online >> Challenges in virus clearance studies design and execution for tissue-based medical devices to be submitted to US FDA

Challenges in virus clearance studies design and execution for tissue-based medical devices to be submitted to US FDA

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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: October 19, 2023 | 3.00 PM - 4.00 PM CET

OFFICIAL LANGUAGE: English

SUBMISSION LINK: https://register.gotowebinar.com/register/5712433931139981142

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

Introduce the US FDA requirements of virus clearance for tissue-based medical devices for the US market and present two case studies:

  • Case study 1: where a stand-alone VC study was validated in order to achieve more than 6Log reductions in input virus titer
  • Case study 2: where multiple steps needed to be identified and validated in order to achieve very high Log reductions
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.