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Register for our Third Annual E&L Seminar!

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E&L Testimonials

Extractables and Leachables Symposium for Drugs and Devices

Thursday, September 19, 2019
8:30 a.m. – 4:30 p.m.
Courtyard Boston-Cambridge Hotel

Join a select group of industry colleagues for a complimentary full day seminar focused on extractables and leachables testing for drug products and medical devices.

Sessions Include:

  • Regulatory Expectations and Industry Guidance for E&L Studies
  • Improving Leachable Study Quality and Efficiency Using Strategically Chosen Time and Storage Conditions
  • Material Qualification Challenges for Combination Products
  • A Lesson Learned from Unexpected E&L Results of Elemental Impurities Assessment During a Multi-Supplier Evaluation
  • Appropriate Scientifically-Defensible Approaches to Assessing the Toxicity of Extractables and Leachables in Drug Products: Using All the Tools Available
  • Design of Leachable Studies for Platform Liquid Drug Products: Leveraging a Bracketing Approach
  • E&L Risk Mitigation Strategies for the use of polymeric consumables for manufacturing of Anti-Sense Oligonucleotides
  • USP Update on Packaging Standards: Revisions and Developments

View the Full Agenda and Register for FREE