WATERS Webinar: Managing Method Variability for Risk-Based Change
Join Our Webinar Series
Managing Method Variability: A Foundation for Risk-Based Change - Session 1
Wednesday, September 10
18:00 Greek Time
Overview
Analytical variability can compromise product quality, regulatory compliance, and patient safety, especially when justifying post-approval changes. Join us for a three-part webinar series, “Managing Method Variability: A Foundation for Risk-Based Change,” featuring former FDA Investigator of the Year Peter Baker (President of Live Oak QA), as we explore how to identify, monitor, and control variability in analytical methods.
Each session offers practical insights, real-world examples, and live Q&A to help you build a scientifically sound case for method adjustments while maintaining compliance.
Session 1
Controlling Analytical Variability to Justify Change and Ensure Compliance
To meet regulatory expectations, analytical methods must be scientifically justified, validated under real-world conditions, and supported by robust data. This session explores how to identify critical sources of variability, interpret FDA warning letters, and avoid common compliance pitfalls.
Presented by
Peter Baker
President
Live Oak Quality Assurance LLC
Dr. Stephanie Harden
Senior Manager, Small Molecule Core Solutions – LC-MS
Waters Corporation