Topics to be addressed include:

  • Explore Materials Used to Fabricate Container Closure Systems and the Impact on Extractables and Leachables
  • E&L Considerations in the Qualification and Validation of Single-use Systems
  • Development and Validation of Analytical Methods for Analysis of Organic Leachables in Drug Products
  • Current Extractables/Leachables Thinking: Impact on the E&L Approach of an Elastomeric Closure Supplier
  • Replacement of Controlled Extraction Studies for PODP E&L Documentation
  • Detection of Glass Particles, Flakes or Lamellae in Tubular Glass Vials


In-Depth Pre-Conference Workshop:

Regulatory Considerations for Extractables and Leachables
~ Dennis Jenke, Ph.D., Principal Scientist, Technology Resources Division, Baxter Healthcare Corporation

Representation from:

  • Baxter Healthcare Corporation
  • Helvoet Pharma
  • Material Needs Consulting, LLC
  • Merck and Company
  • Novo Nordisk A/S
  • NSF Pharmalytica
  • Pall Life Sciences
  • Rumpler Technologies
  • Solvias AG
  • Eakins and Associates
  • Vanasyl LLC
  • WEST Pharmaceuticals

File Type

MP4, Slide Deck


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