Extractables and Leachables USA Conference
Extractables and Leachables USA Conference
May 21-22, 2024 | Bethesda, Maryland
WuXi AppTec is proud to be exhibiting at Extractables & Leachables Summit April 18-19, 2024.
About the Extractables and Leachables USA Conference
Since 2006, Smithers Extractables and Leachables USA conference has been supporting the advancements in the E&L industry while keeping the industry informed and up to date on new regulations and testing protocols. This event offers the industry a unique opportunity for E&L experts to gather and discuss the latest updates on regulations, best practices, compliance, case studies, biocompatibility, and more. Attendees network, build beneficial relationships, and hear diverse perspectives on issues facing the E&L industry in both the US and globally, delivering high level insight into the market and global landscape.
Speakers
Presenter: Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology
Title: The differences between ISO 10993 (Medical Device) and USP <1663> and <1664> (Combination Drug Product): A Path to Approval-The Regulatory Journey of a Combination Product
Abstract: U.S. regulatory approval is rarely smooth sailing for any medical product and for combination products the journey can be filled with unexpected detours if you are not properly prepared. Understanding the regulatory landscape before you develop your test plan can get you to your destination on time. We will walk through:
- Why understanding the primary mode of action is important
- How a presub meeting can set you on a clear path
- What are the differences between USP and ISO methods when it comes to Extractable/Leachable testing
- When to apply USP<1663>/USP<1664> and/or ISO 10993 parts 17 and 18 in your test plan
Finally, we will navigate a combination product case study and explore some of the hidden pitfalls encountered during the journey.
Attending the Extractables and Leachables USA 2024 Conference?
Plan to schedule time to speak with one of our subject matter experts in the area of medical device lab testing.