Explore and Engage with the USP & Waters in Public Standard Development and Radiopharma
Join Our Experts from the USP and Waters on a live webinar!
Heather Joyce, Ph.D. (United States Pharmacopeia) and Kenny Berthelette (Waters Corporation) will lead an engaging session on guiding you through key strategies for navigating regulatory updates and improving analytical reliability.
You'll learn how to: Monitor open comment periods and Calls-for-Data to uncover timely, actionable insights. Use practical tools to filter IRA documents and set up alerts for standards relevant to your work. Review real-world examples showing how consumable and hardware inertness can influence degradation studies and ensure more reliable results.
Don’t miss this opportunity to gain practical knowledge from industry leaders and valuable takeaways to support your goals.
Key learning objectives
- Learn how to track open comment periods, discover Calls-for-Data, and leverage commentary for actionable insights.
- Practical Tools and Features: Explore filtering strategies for IRAs and how to request alert notifications for specific standards.
- See real-world examples demonstrating how consumable and hardware inertness impact degradation studies and reliable results
Who should attend
Pharmaceutical R&D and QC laboratory staff, Contract research and manufacturing organizations (CROs/CMOs), Regulatory affairs professionals
Presenter: Heather Joyce, Ph.D. (Senior Manager Small Molecules, US Pharmacopeia)
Dr. Joyce joined USP in 2004 as a chemist within USP’s Research & Development Laboratory. It was a great training ground and provided lots of opportunities to use a variety of analytical tools: IR, UV-Vis, LC, GC, IC, ICP, ICP-MS, and GC-MS. Her duties ranged from R&D work to co-authoring peer-reviewed articles to RS evaluations to QC to project review. As the lab’s focus narrowed, she worked collaboratively on a variety of projects to improve general chapters such as <191>, <467>, and <233>. She also helped establish an expanded leadership team and improve the approach to chemical inventory. She transferred to the Small Molecules Department as an Associated Scientific Liaison in February 2011 and she has been supporting various incarnations of the Small Molecules 4 Expert Committees (SM 2010-2015, Chemical Medicines 2015-2020, SM 2020-2025, SM 2025-2030). In 2019, she transitioned to the leadership role of Team Lead. Prior to joining USP, Dr. Joyce received a Ph.D. in Chemistry from the University of Virgina and a B.S. in Chemistry from the College of William and Mary in Virginia.
Presenter: Kenneth D. Berthelette (Principal Scientist, Consumables and Lab Automation, Waters Corporation)
Ken earned his Bachelor’s of Science degree in Professional Chemistry from Bridgewater State University, Bridgewater Massachusetts, in 2010. He has been with Waters Corporation since March 2012 and has worked on several product launches including CORTECS columns, UPC2 Torus and Trefoil columns, and the Atlantis Premier BEH Z-HILIC column. He changed job functions in 2021 and now supports Chemistry Aftermarket initiatives. His focus on applications and customer education have led to several seminars and webinars on topics including method development, method modernization and transfer, HILIC separation techniques, and LC system troubleshooting.
Moderated by: Samuel Seal (Biopharma Market Development Manager, Waters Corporation)
Samuel Seal is a market development manager specializing in the biologics space. He loves LC and MS – especially on how this technology provides benefit and value.
Sam joined Waters in January of 2014 as a Sales Technical Support Specialist in the Irvine office/lab. As a TSS he performed demonstrations on various instruments, provided training for customers, often presented on technical information at varying events, and assisted with troubleshooting from Colorado to Los Angeles.
He previously worked at Pyxant Labs in Colorado Springs, CO where he gained extensive experience developing and validating methods for small/large molecules in bioanalytical assays, agricultural commodities, registration of pesticides, and worker exposure studies. He also has experience in column chromatography, sample extraction, sample clean-up, reporting and data management. Sam has hands on experience with running and maintaining various manufacturers' LC/MS/MS systems. Prior to Pyxant, Sam was a Laboratory Instructor at the University of Colorado at Colorado Springs where he earned his Bachelor of Arts in Biology and Bachelor of Arts in Chemistry.
