🎤  Kelly Thomas        |  ðŸ“…  March 04, 2024    |  ðŸ•’  11 AM Eastern Time US 




DESCRIPTION: 

Learn the key phases of an extractables and leachables (E/L) study, including literature gap analysis and efficient study design as mandated by FDA guidelines for drug and biologics packaging. Given the heightened scrutiny of biotechnology drug products, optimizing E/L testing is essential for conserving time and resources.

Join our interactive webinar for a comprehensive E/L study overview, explore valuable literature sources for preliminary insights, and discover how to bridge gaps in information to streamline your study design. We'll delve into E/L study procedures, data management, and real-world case studies while addressing common sponsor challenges.




Areas Covered in the Session:

  • Understanding the different types of extractable and leachable
  • Why test for Extractables Leachables
  • Challenges presented by E/L studies
  • Sources of E/L information and how to leverage them
  • Testing for Extractables
  • Testing for Leachables
  • Interpretation of the E/L data

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Product Development Teams (Formulation and Analytical)
  • Marketing Departments
  • Documentation Departments
  • Supply Chain Departments

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