EXTRACTABLES & LEACHABLES

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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

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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