Extractables and Leachables West 2025
November 4 - November 5
Including an overview of ICH Guideline for Extractables and Leachables (Q3E), Step 2 Guideline–Don’t miss your opportunity for public comment!
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.
