Designing Effective And Efficient Extractables Or Leachables Studies

🎤  Kelly Thomas        |  📅  Recording Available    |  🕒  90 Minutes

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