Managing Process Performance in Stage 3 Process Validation: Regulatory Expectations for Continued Process Verification

Building on the earlier sessions in this webinar series, this installment focuses on the regulatory framework and inspection expectations surrounding Stage 3 process validation and continued process verification (CPV).

During this session, Peter will provide practical insight into how regulators assess ongoing process monitoring, statistical process control, data trending, and lifecycle management to confirm a continued state of control.

Participants will gain a clear understanding of how to design, implement, and sustain compliant Stage 3 programs that withstand regulatory scrutiny, support risk-based decision-making, and enable effective post-approval change.

A live Q&A will allow attendees to discuss regulatory challenges, common inspection observations, and practical considerations for implementing Stage 3 process validation programs.

This series is designed for analytical scientists, quality professionals, and anyone involved in method validation, transfer, or regulatory submissions.

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: Stephanie N. Harden, Ph.D. (Senior Manager, Small Molecule Core Solutions – LC/MS, Waters Corporation)

Stephanie Harden 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.