Tag Archives: CAPA

ASQ Raleigh Life Sciences SIG meeting

Life Sciences SIG — March 26, 2026

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ASQ Raleigh had its first Life Sciences Special Interest Group (SIG) meeting of 2026 on March 26th. The event was held at the NC Biotech Center, where we are one of the Intellectual Exchange Groups that help build the vibrant Life Sciences community in North Carolina.

Despite the bad evening traffic, eleven people were able to make it to the meeting, where Dr. Elizabeth Gilbert presented “Beyond CAPA: Closing the Quality–Culture Gap in Regulated Industries.”

One of the points of discussion was the increasing number of FDA warning letters in the recent years. What are the potential causes? Dr. Gilbert led the discussion on the gaps in documented systems and lived behavior in many organizations.

Culture, systems, management, and leadership can influence employee behavior and therefore quality outcomes. Many of the participants could relate to these interacting factors from experience. Trust and psychological safety was a critical consideration, e.g. can operators stop the production or bring up issues? It’s hard to have a quality and Continuous Improvement culture without engaged employees who feel valued and empowered.

The meeting ended with a group photo with our new ASQ Raleigh banner! Thanks Dr. Gilbert for the thought-provoking presentation.

ASQ Raleigh Life Sciences SIG attendees gathering at the NC Biotech Center

Want to know more about what we discussed? Come to our next event!

Are you interested in presenting at our SIG meetings? Do you know someone who might be interested in presenting? Please let us know. ASQRaleigh@sections.asq.org

ASQ Raleigh Life Sciences Special Interest Group Meeting — March 26, 2026

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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

 

Photo of ASQ Raleigh SIG meeting attendees

SIG Meeting — April 2025

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On Thursday, April 10th, eight people attended the Raleigh Section of ASQ Special Interest Group (SIG) meeting and had a lively discussion, led by Tim Whetten.

Tim gave a brief introduction to CAPA (Corrective and Preventive Action) which was followed by discussion of experiences and frustrations with the process. Frustrations tended to be around bureaucracies that tend to create too many CAPA projects and that keep CAPA projects open for a long time.

It was pointed out that an organization can perform an investigation for each nonconformance and only launch CAPA projects when the organization determines that the impact and likelihood of recurrence justifies it. Focusing on a few CAPA projects allows an organization to provide attention and resources to those improvement projects that are needed.

In addition, the discussion inevitably touched on various problem-solving tools and factors influencing a Continuous Improvement culture, for example, the roles and responsibilities of CAPA owners, coordinator, and review board. Participants also pointed out common mistakes and misunderstanding in CAPA concepts and practices. For example, a correction is not the same as a corrective action.

The next SIG meeting at Frontier RTP will be on Thursday, May 8, 2025.

ASQ Raleigh Special Interest Group Meeting — April 10, 2025

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The SIG event is participant-driven — we will have open discussion around topics related to the quality profession. We may have a theme but no formal speakers or agenda. Everyone is encouraged to participate in the discussion. So bring your questions and ideas to share with other participants.

Theme of the month: Experiences with CAPA: a discussion led by Tim Whetten

This event is free and open to anyone who is interested in the quality profession. No ASQ membership is required. ASQ members will receive RU credit for participation.

We will meet at Frontier RTP (first floor) at 4:30pm or whenever you can join us. It will be during Frontier RTP’s weekly Out of Office event. It’s a great opportunity to connect with people in the triangle community. More information will be provided to the registered attendees before the event.

Register here.