Transformation of Toxicology data into Specific PDE’s


23rd April 2020 | 10:00am PDT, 1:00pm EST | Kim Li, PhD, DABT, MPH, Amgen Inc |BOOK FREE SEAT

Presented by Kim Li, PhD, DABT, MPH, Amgen Inc.

Dr. Li is a board certified toxicologist with broad experience in R&D and Operations. She joined Amgen in 2004 and is currently the lead toxicologist on the extractables and leachables programs on container closure systems, drug delivery devices and single-use bioprocess systems. Kim is the chair of the Extractables and Leachables Safety Information Exchange (ELSIE) consortium. As a member of the Association for the Advancement of Medical Instrumentation (AAMI) Biological Evaluation Committee, Kim serves as the US expert to ISO/TC 194.

Sponsored by Nelson Labs Europe

Nelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.
Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.


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