Navigating Regulatory Expectations for Extractables and Leachables of Combination Products

This webcast features: Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec

The expectations for extractables and leachables of medical devices (delivery systems) are different than those of typical pharmaceutical applications such as container closure systems or single use systems. Learn about how the FDA reviews combination products and learn about testing expectations. Put these expectations to practice with a case study review complete including common pitfalls in testing.

Key lessons learned:

  • How does the FDA interact internally when reviewing combination products?
  • How is characterization of delivery devices different than container closures or single-use systems?
  • Why is complete characterization important?



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