Webinar - USP <665>/<1665> in Practice: Analytical Methods, Risk Frameworks and Lessons from Across the Industry

Applying new USP <665> and USP <1665> requirements through science-based risk assessment and robust analytical strategies.

As the implementation date for USP <665> approaches, pharmaceutical and biopharmaceutical manufacturers are facing important decisions around material qualification, risk assessment, and extractables testing strategies for single-use systems and manufacturing process components.

In this webinar, part of Intertek's Extractables & Leachables Readiness Series, our experts will share practical insights into implementing USP <665> and USP <1665> through risk-based approaches and scientifically justified analytical programmes. The session will explore how extractables studies can be designed for low-, medium-, and high-risk materials used throughout pharmaceutical production lines, and how data can be leveraged to support compliance while avoiding unnecessary testing.

Drawing on real-world industry experience, we will review case studies spanning a range of manufacturing materials and applications, highlighting common challenges encountered during study design, execution, data interpretation, and regulatory review. Attendees will gain practical guidance on selecting appropriate analytical methodologies, applying risk frameworks effectively, and addressing technical obstacles to support efficient and compliant implementation of USP <665>/<1665> requirements.

Key Learning Points

• Understand the practical implications of USP <665> and USP <1665>
• Apply risk-based approaches to material qualification and extractables studies
• Design extractables studies for low-, medium-, and high-risk manufacturing materials
• Review real-world case studies from pharmaceutical manufacturing systems
• Learn how to address common testing challenges and data interpretation issues

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Susanne Becker

Director of Extractables & Leachables Laboratories, Switzerland

Dr. J. Susanne Becker completed her Ph.D. at the University of Konstanz in analytical chemistry. After seven years of experience in the pharmaceutical industry at Aeropharm and Baxter, she joined Intertek (Schweiz) AG in April 2016 as the Project Leader in E&L and, since 2021, is now the Head of Extractables and Leachables Laboratories