Introduction to Extractables & Leachables (E&L) Webinar Series
Extractables and leachables studies are a critical component of pharmaceutical, biopharmaceutical, and medical device development, with increasing regulatory scrutiny across global markets. This three part webinar series provides a structured progression from foundational principles to practical testing strategies and advanced problem solving, drawing on real world experience from Smithers extractables and leachables experts.
Designed for regulatory, quality, and technical professionals, the series offers guidance aligned with current and emerging expectations, including USP, ICH, FDA, and EU frameworks. Each session is available on demand and may be viewed individually or as a complete learning path.
Part 1: Navigating Extractables and Leachables
This introductory webinar establishes a clear understanding of extractables and leachables, their sources, and their relevance to patient safety and regulatory compliance. It is well suited for teams new to extractables and leachables programs or those seeking a refresher on core concepts and regulatory context.
Topics include:
- Definitions and differences between extractables and leachables
- Common sources from materials, components, and packaging systems
- Overview of global regulatory expectations and guidance
- Risk based approaches to planning extractables and leachables studies
Part 2: Test Programs for Extractables and Leachables
Building on the foundational concepts, this webinar focuses on designing and executing effective extractables testing programs, with particular attention to processing equipment and manufacturing contact materials. The session emphasizes practical considerations and alignment with current USP guidance.
Topics include:
- Overview of USP <665> and <1665> frameworks
- Risk based extraction strategy development
- Selection of extraction conditions, solvents, and time points
- Analytical techniques used to characterize extractables
- Using extractables data to inform leachables risk assessments
Part 2: Overcoming Extractables and Leachables Challenges
The final webinar in the series addresses common and complex challenges encountered during extractables and leachables programs. Through real world examples, the session explores how to identify data gaps, manage change, and maintain regulatory readiness throughout the product lifecycle.
Topics include:
- Assessing the impact of planned and unplanned changes
- Managing data gaps through targeted testing and risk evaluation
- Preparing for USP <661.1> and <661.2> requirements
- Understanding regulatory expectations under ICH Q3E
- Case examples involving unexpected leachables and analytical resolution
About the Series
Together, these three webinars provide a cohesive educational path, moving from foundational understanding to applied testing strategies and advanced problem solving. The series supports organizations seeking to strengthen their E&L programs while remaining aligned with evolving regulatory expectations.
For questions about extractables and leachables testing or regulatory support, contact the Smithers team to discuss your specific application and development needs.
Meet The Expert: