Extractables & Leachables Summit 2022
September 20, 2022 @ 8:00 am – September 21, 2022 @ 5:00 pm
Dr. Mark Jordi will present “Mitigating Response Factor Variation in Application of the Analytical Evaluation Threshold, Large UF or Multiple Detectors”.
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.