Managing Method Variability: A Foundation for Risk-Based Change - Session 1

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 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. Numerous FDA Warning Letters issued post 2019 have included the requirement to vigilantly monitor inter- and intra-batch variability, but what should we be monitoring? This session explores how to identify critical sources of variability, interpret FDA warning letters, and avoid common compliance pitfalls. We will also discuss current guidance used to evaluate post-approval reporting expectations and their impact on product/patient.

Goal: Learn how to generate a risk-based method monitoring strategy, with the goal of eventually demonstrating changes do not compromise product quality, safety, or efficacy.
 

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.