Extractables & Leachables Summit 2023

$695.00

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.

Category:

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

  • Two full days of presentations, panel discussions, and networking
  • The industry’s top experts share their knowledge and lessons learned
  • Learn what you need to know to meet regulatory expectations for E/Ls in drug products, delivery systems, medical devices, and packaging
  • Focus on overcoming common analytical challenges in E/L study design
  • Gain insight into AET’s and uncertainty factors in E/L analysis
  • Explore E&L Assessment in Cell & Gene Therapies
File Type

Slide Deck

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