Webinar On Demand: Overcoming Extractables and Leachables Challenges

Webinar On Demand: Overcoming Extractables and Leachables Challenges
Ensuring the quality of pharmaceutical and medical devices requires a strong understanding of how extractables and leachables can influence product performance, patient exposure, and long-term compliance. As materials, formulations, and global expectations continue to advance, organizations increasingly face complex challenges that must be addressed with informed and well-structured E&L programs.

For teams seeking guidance on how to navigate these complexities, our recent webinar, recorded on November 13, 2025, is now available on demand. Presented by Helen Lewis, a trusted expert with more than 27 years of experience in E&L, analytical chemistry, and regulatory support, this session serves as the final installment in our three-part series.

Watch Part 1: Navigating Extractables and Leachables
Watch Part 2: Test Programs for Extractables and Leachables Processing Equipment

Webinar Highlights:

  • Change Control: Learn how to assess planned and unplanned changes, and maintain regulatory alignment.
  • Identifying Data Gaps: Understand when existing extractables data is insufficient, and how to address gaps through testing and risk evaluation.
  • USP <661.1> and <661.2> Readiness: Review the upcoming requirements for plastic materials and packaging systems, and the tests needed for compliance.
  • Regulatory Updates: Explore current expectations for E&L, including the new ICH Q3E risk-based framework.
  • Case Studies: See examples of packaging changes, unexpected leachables, and the analytical steps used to resolve challenges.

Access the On-Demand Webinar Below:

Download the slides:

Smithers-Overcoming-E-L-Challenges-Slides-2025
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