August 20, 2019 | Tuesday | 11AM EDT
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?
About the presenter
Sandi Schaible is Senior Director, Analytical Chemistry and Regulatory Toxicology at WuXi AppTec. With over 25 years’ experience, Ms. Schaible is responsible for oversight and direction of WuXi AppTec’s Analytical Chemistry department in St Paul, Minnesota. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterization and target analysis testing, method development, method validation as well as standardized testing including compendial testing.