Register for our Third Annual E&L Seminar!
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.
- 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