Webinar On Demand: Navigating Extractables & Leachables

Webinar On Demand: Navigating Extractables & Leachables
Ensuring the quality of pharmaceutical and medical devices is a critical endeavor. A key aspect involves understanding and extractables and leachables that can migrate from packaging, manufacturing components, or devices into a drug product or directly to a patient.

For those new to E&L testing or seeking deeper insights into regulatory landscapes, our recent webinar, recorded on July 24, 2025, Introduction to Extractables and Leachables: Navigating Extractables and Leachables is now available on-demand. Presented by Helen Lewis, an expert with 27 years of experience in the field, this webinar if the first in a three-part series that offers a comprehensive overview of E&L.

Webinar Highlights:

  • E&L Distinction: Understand the difference between extractables and leachables
  • Source of Leachables: Explore common orgins of leachables
  • Regulatory Landscape: Gain insight into relevant FDA and EU regulations along with USP and EP Chapters, and ISO  and ICH guidelines
  • Study Phases: Risk-based approach to E&L studies

Access the On-Demand Webinar Below:

Download the slides:

Smithers-Navigating-Extracables-and-Leachables-Slides-2025
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