Smithers expert Paul Cummings
is giving a presentation on challenges in leachable method development
and validation at the upcoming Smithers E&L USA 2020
conference in October* in Bethesda, Maryland.
“Because every combination of analyte and drug product is unique, it can be difficult to develop and validate the right analytical method right away,” said Cummings. “If you decide too quickly that a method is ready for validation, you can encounter unexpected roadblocks that slow down the process significantly.”
Cummings will present several case studies of validation processes that did not proceed according to plan and discuss strategies to increase the probability of success.
“The Smithers E&L conference is designed to help attendees deepen their understanding of the industry, including best practices,” said Ashli Speed, Conference Producer, Smithers. “Paul’s presentation illuminates some common challenges and how to anticipate them, giving our attendees practical tips for keeping their processes running smoothly.”
Cummings is also leading a pre-conference masterclass on extractables and leachables
with Senior Independent Consultant Dr. Daniel Norwood. Some topics on the masterclass agenda
- History of the FDA
- United States regulatory policy and standard setting
- Risk assessments in manufacturing systems
- Extractable elements
- Best practices for USP General Chapters <1663> and <1664> | download our webinar on <1663> and <1664>
The workshop takes place on Monday, October 26. The conference continues on October 27 and 28. Use code EL20SAVE10
to save 10% off conference registration.
*Originally planned for April, this event was rescheduled for October due to the coronavirus situation.