Regulatory Requirements and Analytical Strategies to Analyze Extractables and Leachables

Register Free:https://www.chromatographyonline.com/lcgc_w/requirements

Event Overview: Pharmaceutical manufacturers have come under growing pressure to perform sensitive and accurate analytical studies to detect, identify, and quantify extractable and leachable compounds (E&Ls) which may be potentially toxic or have otherwise undesirable effects on the efficacy of drugs. Even as regulatory guidance related to the application, performance, and reporting of E&L studies increases and examples and data accumulate, E&L analysis is still an evolving area of investigation.

The webcast will provide recent regulatory updates for extractable and leachable studies for both medicinal devices and medical products. It will highlight similarities and differences between these similar but different regulations. The webinar will also cover the factors and decisions required to design and execute a successful study.

Key Learning Objectives:

Participants Will Learn:

• Recent regulatory updates about E&L studies
• Strategies for successful E&L studies

Speakers: Dr. Andrew Feilden, European E&L Strategic Director, Hall Analytical

Times and Dates: Europe: Tuesday, December 8, 2020 at 9am EST| 2pm GMT| 3pm CET

US: Tuesday, December 8, 2020 at 2pm EST| 1pm CST| 11am PST

On Demand until Dec. 8, 2021.

Sponsor: Agilent

Register free:​ https://www.chromatographyonline.com/lcgc_w/requirements