Considerations for Navigating ISO 22442-3 Viral Inactivation Studies
About
Date/Time
March 20, 2024
EN ISO 22442 is the standard for medical devices that use tissues from preclinical models and their derivatives. Manufacturers must show that they can effectively inactivate and remove viruses from raw materials and finished products. The types and amounts of non-human materials in medical devices differ, including bovine/porcine heart valves and hemostatic sponges, among others. Join our NAMSA experts as we explore key aspects of your viral inactivation testing program.
Our speakers will explain the use of non-human tissue and derivatives in developing medical devices. They enhance performance, stabilize formulations, and improve properties.
Attendees will gain insights on:
- When to consider a viral inactivation study
- Steps in the study process and what to think about before starting
- Customizing viral inactivation studies and potential challenges
- Considerations for molecular screening and batch release
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Speaker
Chris Ball, PhD
Technical SpecialistChris, who joined NAMSA in 2022 through the acquisition of Perfectus Biomed, is responsible for the management and delivery of a range of bespoke projects in microbiology and molecular. Chris develops and leads R&D initiatives, plans and executes client projects and provides technical expertise to support operational processes. Chris has worked as a study director and obtained profound knowledge of setting up, planning, and performing viral clearance studies. Before working with NAMSA, Chris obtained his PhD from the University of Liverpool in 2014 and then went on to investigate molecular and immunopathogenesis aspects of infectious bronchitis virus (IBV), avian metapneumovirus (aMPV), Mycoplasma spp and other poultry diseases, using in vitro, ex vivo and in vivo systems in his postdoctoral research associate position, before joining Perfectus in 2021.
Jane Arnold-Round
Principal Regulatory ConsultantJane Arnold-Round has over 25 years of experience in the medical device industry, working with a broad range of medical device technologies and organizations from start-ups to multinationals. She worked as a Notified Body reviewer for over 15 years at BSI as a Medical Device Product Specialist with particular responsibility in the wound-care sector. Prior to joining NAMSA in 2018, she was a Regulatory Consultant for 14 years. Jane’s current focus involves complex submissions for high-risk devices, including development of regulatory and clinical strategies, design dossier and technical file compilations, device-drug consultations, clinical evaluations and regulatory due diligence.
Thomas Miles
Head of Technical Operations (NAMSA Cheshire)Tom joined NAMSA in 2022 through the acquisition of Perfectus Biomed and is responsible for technical oversight and facilities management for laboratory operations at Cheshire. He has extensive experience in cell culture, virology assays, multiple biological therapeutics, and in vitro toxicology. Drawing on a broad experience in the MedTech/Pharmaceutical industry, Tom supports client project development with a Techno-commercial mindset. Tom has worked in both operational/project management and technical-focused roles, supporting medical device and pharmaceutical manufacturing, before joining Perfectus in 2021.