The Chemical Characterization Puzzle: Is There a Solution?

About

Date/Time

August 2, 2023

In today’s ever-changing regulatory environment for the biological safety of medical devices, manufacturers are often faced with the challenge of material or chemical characterization. Although ISO 10993–18 provides a good guide for this evaluation, regulatory expectations and evolving science continue to provide challenges in these ever-important screening studies. Regulatory focus remains diligent on the screen for confirmed and confident chemical entities that may leach from medical devices and their toxicity levels. In this webinar, NAMSA experts discuss the top challenges for today and how to address them. We highlight many of the items that are seen in regulatory responses, both in the US and also from global agencies around the world.

Attendees can expect to walk away with a better understanding of:

Designing material or chemical characterization studies with the best approach to generating data for global agencies
How device manufacturers can work with a laboratory to provide information, ensuring the best results for a study
Identifying unknowns

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Speaker

Charles Ducker, PhD

Senior Director North American Analytical Services

Dr. Charles Ducker is the Senior Director North American Analytical Services for NAMSA’s chemical characterization group where he oversees the design and execution of extractables and leachables testing programs for the medical device industry, LC/MS, LC/MS/MS, GC/MS, ICP/MS and ICP-OES technology. Specializing in LC/MS analysis, Dr. Ducker has 20 years of experience in the CRO and biotech industries and has earned a Ph.D. in Biochemistry/Molecular Biology from The Pennsylvania State University, as well as a B.S. in Biology from Millersville University.

Angela Sanchez

Associate Scientific Director

Angela Sanchez is the Associate Scientific Director at NAMSA. Her work focuses on chemical characterization of medical devices. She specifically leads regulatory compliance of ISO 10993-18 analyses. Angela received her Bachelors of Science at Wayne State University and went on to graduate school at Colorado State University. She has over 20 years of chemistry experience. Previously, she has worked as a synthetic organic chemist in the field of RNA interference for greater than 10 years. She has also served as a Technical Director and Senior Scientist in leading CROs.