Navigating the Challenges of Residual Solvents in Pharmaceutical Products According to USP <467> <1467> and ICH Q3C Regulatory Guidelines
When: July 24, 2019 11:00am CST
Understanding the regulatory expectations of residual solvents is not always easy, especially the recently published changes from the USP. During this webinar, Eurofins BioPharma Product Testing’s experts will provide a detailed summary of the changes and logical approaches for satisfying the new USP instruction, including approaches for a wide range of product types to help solve your residual solvents challenges with practical and cost effective strategies. We will share case studies addressing problematic solvents and the technical path forward. This webinar will also include:
- A Review of USP Screening Residual Solvents for Excipients, Drug Substances and Drug Products
- An Overview of limit vs. quantitation procedures and <1467> validation
- Options for Class 2, Mix C and Class 3 Residual Solvents testing
- Case studies for problematic solvents and the strategy Eurofins BioPharma Product Testing uses for successful testing
- Discussions on NCE or non-compendial test articles and ICH Q3C
About the Speakers:
Harley Wilcox, Senior Scientific Advisor – Small Molecule, Eurofins BioPharma Product Testing
With more than 30 years of experience in pharmaceutical drug development/research, Mr. Wilcox has held positions in chemical development, synthetic drug discovery, analytical development, CMC regulatory, supply chain, middle management, and CRO business development. He is serving as a Senior Scientific Advisor with a focus on small molecule at Eurofins BioPharma Product Testing. Mr. Wilcox earned a bachelor’s degree in chemistry at the University of Missouri, Kansas City, as well as a master’s degree in business administration from Florida Institute of Technology with a focus in healthcare management.
Erika Guerrero, Principal Scientist-Group Leader, Eurofins BioPharma Product Testing
With nine years of experience, Ms. Guerrero is well versed in residual solvents testing according to compendia procedures, including USP <467>, as well as client/vendor methods and Eurofins-developed methods. As a Group Leader at Eurofins BioPharma Product Testing, she oversees a Method Establishment Team to install new methods for chromatography, small instruments and wet chemistry techniques. She earned a bachelor’s degree in chemistry from Mansfield University.
Danielle Newton, Senior Scientist-Group Leader, Eurofins BioPharma Product Testing
With 16 years of Raw Materials Analytical testing experience, Ms. Newton is versed in various wet chemistry and small instrumentation techniques and oversees the Chromatography Method Establishment Team for Eurofins BioPharma Product Testing’s Lancaster facility. With a focus on residual solvents testing, Ms. Newton serves as the company’s leader in implementing the changes associated with the recent update to the USP residual solvents general chapter testing. She earned a bachelor’s degree in biochemistry and molecular biology from Lebanon Valley College.