Faculty: Kelly Thomas | Code: FDB3418
Learn the key phases of an extractables and leachables (E/L) study, including literature gap analysis and efficient study design as mandated by FDA guidelines for drug and biologics packaging. Given the heightened scrutiny of biotechnology drug products, optimizing E/L testing is essential for conserving time and resources.
Join our interactive webinar for a comprehensive E/L study overview, explore valuable literature sources for preliminary insights, and discover how to bridge gaps in information to streamline your study design. We'll delve into E/L study procedures, data management, and real-world case studies while addressing common sponsor challenges.
Areas Covered in the Session :
Who Should Attend:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.