Patricia Stewart Flaherty
Bio:
Patricia has over 35 years of global experience in clinical and commercial quality assurance, regulatory affairs, validation, operations, and capital project management. Her distinguished career spans leadership roles in both public and private sectors, including serving as Senior Advisor for Regulatory & QA on Medical Countermeasures, at the U.S. Department of Health and Human Services-BARDA and holding senior executive positions at major biotech organizations across North America and Europe.
Patricia specializes in QA Compliance, inspection readiness, GxP auditing, regulatory compliance, capital project leadership, and CQV strategy. She has successfully guided multimillion-dollar facility startups, managed international site transfers, and executed inspection and remediation efforts for multi-national companies.
An advocate for industry education and advancement, Patricia serves as Board Member and Secretary for the ISPE South Central Chapter, is a past president of the ISPE San Diego Chapter, and has made numerous presentations and published articles. She holds a Master’s degree in Regulatory Affairs from Northeastern University and will complete her MBA at Texas A&M University in December 2025.
Topic: Enhanced Risk Assessment Strategy to Support Contamination Control Strategy and Vendor Management
Enhanced Risk Assessment Strategy to Support Contamination Control Strategy and Vendor Management is a specialized course designed for professionals in the biotechnology and pharmaceutical industries who are responsible for maintaining regulatory compliance and product quality. The course provides a structured framework for integrating advanced risk assessment methodologies into a company’s Contamination Control Strategy (CCS) to address microbial, particulate, and cross-contamination risks across manufacturing operations. Participants will learn how to analyze contamination pathways, quantify risks, and align risk mitigation activities with FDA, EMA, and ICH regulatory expectations to support continuous assurance of product safety and efficacy.
In addition to contamination control, the course emphasizes the critical role of vendor management in mitigating supply chain vulnerabilities that jeopardize closure. Attendees will explore best practices for supplier qualification, auditing, and ongoing performance monitoring, with practical tools for integrating vendor-related risk factors into a holistic CCS. Case studies will demonstrate how enhanced risk assessments can strengthen decision-making, reduce regulatory exposure, and ensure resilient, compliant manufacturing processes.
Schedule:
6:00 - 6:30 Section Updates
6:35 – 8:30 Speaker Presentation
Location:
VIRTUAL
Cost / RUs:
This is a free event for ASQ members & guests.
0.1 RU/hour shall be awarded
Registration:
Please be sure to register for this event if you plan to attend.