Session 1: Identifying the Need for Method Adjustment and Mitigating Risk

Strategies to Reduce Risk When Performing LC Method Adjustments

As laboratories face evolving materials, instrumentation, and regulatory expectations, understanding the circumstances that justify changing methods is essential. This is especially relevant as more methods are developed on higher performing UHPLC instruments and high-efficiency, sub-2-µm particle columns. These UHPLC methods are suitable for many systems, however, method adjustment may be needed to perform the analysis on HPLC systems. While there are guidelines for performing method adjustments, additional factors, including instrumentation, can impact the performance of the scaled method.

This three-part webinar series on analytical method adjustment in pharmaceutical analysis is designed to provide practical insights into when and how to adapt validated analytical methods.

Topics include:

• How to assess risk when performing method adjustments and identify some control strategies for more common method and instrument contributors
• How to adapt an analytical method, focusing on the impact of LC instrument characteristics and their impact on scaling from UHPLC to HPLC Columns
• Practical tips and strategies to consider when adjusting LC methods across a variety of instruments

This series is ideal for analysts, QA professionals, and method developers seeking actionable guidance rooted in real-world lab experience.

Session 1: Identifying the Need for Method Adjustment and Mitigating Risk

This session will focus on the foundational principles of method adjustment. Topics will include identifying and controlling for potential contributors that necessitate method adjustment, from method conditions to instrumentation.

Attendees will learn the role instrumentation can play in method adjustment with a focus on differences on UHPLC and HPLC systems. Risk assessment strategies, for controlling variability, will be presented with a focus on meeting method suitability.

Presenter: Paula Hong (Senior Manager, Research Support, Waters Corporation)

Paula Hong is a Senior Manager in the LC-MS business unit at Waters Corporation. She received her B.S. in Chemistry from Bucknell University (Lewisburg, PA) and her Ph.D. in Inorganic Chemistry from The University of Pennsylvania (Philadelphia, PA). Paula has over 17 years of experience in LC and LC-MS applications and analytical chemistry, including amino acid analysis, biopharmaceutical applications and method development. Her more recent work has focused on the instrument attributes that affect method transfer and method lifecycle management. She currently manages a team of scientists who support research and development of Waters chromatographic systems.