Managing Method Variability: A Foundation for Risk-Based Change - Session 2
Analytical methods are essential to ensuring pharmaceutical product quality, regulatory compliance, and patient safety. However, their reliability and reproducibility can be compromised by multiple sources of variability—including reagent quality, instrument performance, operator technique, sample preparation, and data processing. Understanding and controlling these sources is critical, especially when justifying post-approval changes to validated methods.
This three-part webinar series features expert Peter Baker (Live Oak QA, Austin, Texas) and focuses on the importance of identifying, monitoring, and documenting variability within analytical workflows. Through open discussion and real-world insights, participants will gain a deeper understanding of how to build a scientifically sound case for method adjustments while maintaining regulatory compliance. Each session includes a live Q&A to encourage interaction and address specific challenges.
Session 2: Tools for Reviewing and Managing Method Variability
This session introduces practical tools and strategies for identifying and managing variability, including risk assessments, control charts, method performance trending, and validation planning. It also explores how digital systems and AI can support continuous monitoring and decision-making. Previously, monitoring tools or dashboards may have been avoided due to the inability to meet traditional CSV requirements. In this webinar we discuss how to overcome these historical barriers using quality risk management to meet current regulatory expectations for vigilant operations management oversight of analytical methods.
Goal: Discover tools that help minimize variability and support scientifically justified post-approval changes.
Presenter: Peter Baker (President, Live Oak Quality Assurance LLC)
Peter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since April 2019. Prior to consulting, Peter spent 11 years as a U.S. FDA Drug Investigator, with most of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity and has special interest in data governance and compliance with 21 CFR Part 11. Live Oak focuses on training and employee empowerment in critical thinking, with the goal of improving the quality of medicines through good data management.
Presenter: Dr. Stephanie Harden (Senior Manager, Small Molecule Core Solutions – LC-MS, Waters Corporation)
Stephanie Harden, Senior Manager at Waters Corporation, leads the Product Marketing and Scientific teams for Waters small molecule HPLC portfolio. With over 25 years of experience in product and segment marketing, she has a proven track record in strategic program development, cross-functional leadership, and market-driven innovation. Her work connects scientific insight with commercial strategy to drive customer-focused solutions and sustained business growth. Stephanie holds a PhD in Chemistry from the University of Bristol, UK, and is a widely cited author.
