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Extractables & Leachables West Virtual Summit Learn More

Extractables & Leachables West Virtual Summit, 2021

Ensuring Quality, Safety, Suitability, & Regulatory Compliance for Drugs, Biologics and Medical Devices

DATE

November 11-12, 2021

LOCATION

Virtual Conference

ABOUT Extractables & Leachables West Coast Summit 2021

This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical and biotech industries, including drug packaging and delivery components, single-use systems, medical devices, and parenteral drug products. In addition, we will focus closely on the keys to satisfying recent revisions to several applicable USP chapters, ICH Q3E, and the recently revised standards contained in ISO 10993.

Based on the recently published requirements and recommendations of ISO 10993-18:2020: Chemical characterization of medical device materials within a risk management process, and regulatory expectations for chemical characterization of medical devices, the outcome of chemical characterization is often very large numbers of chemicals that need to be assessed by the toxicologist in the toxicological risk assessment. ISO 10993-17 is currently under revision to provide tools for the toxicologist to interpret these chemical characterization data to better and more consistently support medical device safety. Recent updates to draft ISO 10993-17 will be provided in addition to strategies for handling large amounts of chemical characterization data, including organization, work flow and risk mitigation.

BOOTH INFO

Virtual Conference

MEET WITH AN EXPERT

Dr. Sherry Parker, Senior Director of Regulatory Toxicology, WuXi AppTec will be presenting updates on ISO 10993-17, Toxicological Risk Assessment of Medical Devices: Tools and Tips for Handling Large Amounts of Chemical Characterization Data.