Extractables & Leachables Virtual Summit 2020

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

July 30-31, 2020, Online, Eastern Daylight Time

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 and the recently revised standards contained in ISO 10993.

Why Attend:

  • Two full days of presentations, panel discussions, and networking
  • Over 15 industry experts share their knowledge and lessons learned
  • Full coverage of best practices in materials and chemical characterization of medical and Pharma devices and their primary and secondary packaging
  • Key insights from industry working groups - USP and BPOG
  • Know the importance of uncertainty factors in E/L analysis and study design

Highlights of Extractables & Leachables 2020

*Extractables/Leachables Studies: Are You Certain About that Uncertainty?

~Dennis Jenke, Triad Scientific Solutions

*Evaluation of Material Quality Attributes of Polymerics Used in Cell Therapy Products Manufacturing

~Ping Wang, Johnson & Johnson

*Case Study: Medical Device Toxicological Risk Assessment Following New Principles of ISO 10993-17

~Sherry Parker, WuXi AppTec

*Key Concepts and Practices for Effective and Compliant Chemical Characterization of Med Devices (ISO-10993-18)

~Ted Heise, MED Institute

*CDRH Scientific Perspective on Chemical Analysis for Medical Devices

~Berk Oktem, FDA

What People Are Saying about Extractables & Leachables Summit!

"I go to a lot of Extractables/Leachables conferences, and this was an excellent one."
~ Senior Scientist, Boehringer-Ingelheim

"This is a valuable conference, with many expert speakers."
~ Product Manager, EMD Millipore

"Great mix of topics and networking sessions."
~ Deputy Director, Sanofi Pasteur

"I am new to the med device E/L scene, so I attended as a learning opportunity... I feel the conference was very informative and balanced various subject areas very well. I'll definitely plan on attending again."
~ Research Toxicologist, NSF International

Extractables & Leachables Summit 2020 Sponsored By

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