Extractables & Leachables Virtual Summit 2021

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

June 2-3, 2021, Online EDT

This two-day virtual 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, ICH Q3E, and the recently revised standards contained in ISO 10993.

Why Attend:

  • 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 FDA expectations for E/Ls in drug products, delivery systems and medical devices
  • Focus on overcoming common analytical challenges in E/L study design
  • Gain insight into AET's and uncertainty factors in E/L analysis

Pharma Ed's Extractables & Leachables Summit Features In-Depth Coverage On

  • Designing and Improving Risk-Based Assessment of E&L Data for Drugs, Biologics, and Medical Devices
  • Implementing ISO 10993-17 & ISO 10993-18 Standards
  • AETs and Response Factor Variation for E/L Studies
  • Meeting Regulatory Expectations for E&Ls in Drug Products, Delivery Systems, and Medical Devices
  • Regulatory Strategies in the Age of Covid-19: Lessons Learned
  • Chemical Characterization in Biocompatibility for Med Devices
  • E&L Considerations in the Qualification and Validation of Single-Use Systems
  • Addressing E&Ls from Bioprocessing Equipment & Product Packaging Perspectives

What People Are Saying About Pharma Ed's Virtual Conferences

"Great to be a part of the virtual summit! Wonderful talks throughout! Please count me in for future events."
~ Senior Director, J&J

"This was my first virtual conference and it was much better than I expected. The willingness of the participants to stick around and chat in the off times was really nice also. Thanks for organizing and making this happen."
~ Independent Consultant, Mycroft Medical

"I had a great experience with the online platform this year. . . . I think this was very well done and made for two very informative shows."
~ Vice President, Jordi Labs

"This has been a great meeting."
~ Research Materials Engineer, FDA

"I have thoroughly enjoyed the E&L summit. Thanks so much for organizing it."
~ Analytical Chemist, FDA

"Congratulations with the event! It is really unbelievable how well this is organized, it is like you have always organized virtual events all your life!"
~ Scientific Director, Nelson Labs

Extractables & Leachables Virtual Summit 2021 Sponsored By