Session 4: A new paradigm for Risk Based qualification in the Single Use era
3:00 PM – 3:45 PM | West Red Level, Suite 81
A new paradigm for Risk Based qualification in the Single Use era
When using all COTs type SUS equipment, there is little need for sophisticated Equipment risk assessments of the equipment, or extensive IOQ testing. Applicable ASTM E-2500 guidance that is not well utilized is that the level of (Qualification) effort should be commensurate with the level of complexity and novelty of the technology. SUS equipment is no longer novel, nor custom as was Bio-Pharma equipment in the past. Thus a dramatically streamlined approach can be employed for the C&Q life cycle, from streamlined URSs to simplified IOQs. Three Take Aways: 1) How to simplify URSs for fast development and approval 2) How to minimize C&Q efforts 3) Key sources of Risk to be mitigated in Single Use systems 4) ASTM resources available to help in Single Use programs.
Speakers:
Lou Traglia, Principal, 28 Sep Consulting
Marion Glenn, CMC Director, Resilience, Inc.
Sponsored by:
Biographies:
Lou Traglia, Principal, 28 Sep Consulting
Louis Traglia is a C&Q expert with over 20 years of experience who has managed numerous projects throughout the United States. He is an expert if ASTM E-2500 implementation including risk assessments and the C&Q life cycle. He is also a member of ASTM E-55 and a contributor to the E-2500 standard. Second Speaker is Marion Glenn, currently serving as a Technical Product Lead, and has worked in MS&T for Genentech and Resilience.
Marion Glenn, CMC Director, Resilience, Inc.
Marion Glenn is a CMC director at Resilience managing Technical Project execution across diverse modalities for large and small biotech. With over 19 years of experience in the field, Marion is a seasoned biotechnology engineer in Biologics and Gene Therapy manufacturing processes. She started her career at Genentech, California, later acquired by the Roche Group. Her technical expertise spread a large spectrum from cell line development, cell culture process development and characterization, process and equipment validation, Single Use Technologies and Technology transfers. She joined Resilience in 2021 to bring the Marlborough facility online. She received a Master of Science in biochemical engineering from the Polytech Engineer School of Marseille, FRANCE and her Bachelor of Science in Microbiology and cell physiology from the University of Aix-Marseilles II.
