This event is free and open to the public. No ASQ membership is required. ASQ members will receive RU credits for attending.

Title: Beyond CAPA: Closing the Quality–Culture Gap in Regulated Industries

Abstract:

Regulatory findings rarely stem from a lack of procedures — they stem from gaps between documented systems and lived behavior. FDA warning letters and inspection trends increasingly point to weaknesses in quality culture, psychological safety, and leadership accountability rather than technical deficiencies alone.

This interactive session explores how Continuous Improvement professionals can move beyond reactive CAPA management toward proactive quality culture integration. Participants will examine common root causes behind recurring deviations, explore the role of psychological safety in error reporting, and discuss practical tools for strengthening governance maturity.

The format would include presentation content followed by facilitated group discussion to encourage participant engagement.

Presenter:

Dr. Elizabeth Gilbert, DBA, ASQ CQA

President, Trinity National Consulting | Senior Advisor & Executive Consultant, PQE Group

Bio:

Dr. Elizabeth Gilbert is President of Trinity National Consulting and a Senior Advisor and Executive Consultant with PQE Group, supporting organizations in regulated industries with quality systems strategy, governance maturity, and regulatory readiness. She is an American Society for Quality (ASQ) Certified Quality Auditor (CQA), CQIA Subject Matter Expert, ASQConnEx course instructor and DBA Chair with more than 20 years of experience in pharmaceutical, biotechnology, medical device quality systems, and academia.

Throughout her career, Dr. Gilbert has led high-risk GMP investigations, environmental monitoring programs, and inspection readiness initiatives across global life sciences organizations, supporting compliance with FDA, EU GMP, and ISO quality standards.

Her research and consulting focus on the intersection of quality culture, leadership accountability, and system maturity, examining how psychological safety and governance structures influence deviation reporting, CAPA effectiveness, and continuous improvement outcomes in regulated environments.

Register here.

For questions, contact Life Sciences Special Interest Group (SIG) Chair, Fang Zhou, at ASQRaleighSIG@gmail.com