Extractables & Leachables – West
Extractables & Leachables – West
November 2-3, 2023 | La Jolla, California
WuXi AppTec is proud to be exhibiting at the Extractables and Leachables – West on November 2-3, 2023.
About Extractables & Leachables – West
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. We will focus closely on the keys to satisfying recent revisions to several applicable USP chapters, FDA guidances & other international regulatory requirements for best practices in materials and chemistry characterization for drugs, biologics, delivery systems, and primary & secondary packaging.
Presentations
Sandi Schaible, Senior Director of Analytical Chemistry & Toxicology, WuXi AppTec
Date: April 18th, 2023
Biological Risk Assessment in E&L Study Design
Regulatory bodies are looking for objective evidence of safety. Designing your studies should take into account the biological risk assessment process (ISO 10993-1). This presentation will cover several key topics in this field, including:
- Importance of the Risk Assessment and overview of the process
- Key inputs for the Risk Assessment and how they relate to the E/L study
- Essential components of an E/L Study
Attending Extractables & Leachables – West? Meet With an Expert
Stop by and see us at the even and schedule time to speak with one of our subject matter experts in the area of drug development lab testing or medical device lab testing.