In today’s regulatory landscape, pharmaceutical and biopharmaceutical manufacturers are under growing pressure to ensure safety and compliance, particularly around extractables and leachables (E&L). Navigating USP requirements, defining testing needs, and assessing risk can seem complex, but it doesn’t have to be uncertain.
This expert-led webinar will outline a clear, step-by-step framework for E&L risk assessment — from component selection to risk scoring and characterization level assignment — while also providing practical strategies to reduce testing requirements through effective mitigation, all within regulatory expectations. Designed for teams developing new products, refining processes, or preparing for submissions, the session will equip attendees with tools to take a more structured, efficient, and compliant approach to E&L management.
Key takeaways include how to evaluate applicable materials and determine the appropriate level of characterization, apply a structured method for assigning risk scores, and implement mitigation strategies that can minimize testing needs for specific components.
Key Learning Objectives:
Evaluating applicable materials to determine the appropriate level of characterization.
Applying a structured method for assigning risk scores.
Implementing mitigation strategies that can minimize testing needs for specific components.
Vicki Ward, Ph.D., Director, Pace® Life Sciences – Research Triangle Park
Ward is the Director at Pace® Life Sciences’ Research Triangle Park, NC laboratory. She holds a Ph.D. in Chemistry from North Carolina State University and brings more than 25 years of pharmaceutical industry experience.
Ward leads the characterization of packaging and manufacturing process materials for both small- and large-molecule products, overseeing the Extractables & Leachab
les and Inorganics departments. She also manages the Analytical Development and Quality Control teams, with responsibilities spanning method transfers, method development, and validation across all stages of drug product development.