Tag Archives: Culture

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

 

ASQ Raleigh SIG meeting

SIG Meeting — November 13, 2025

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A group of seven people attended the November Special Interest Group (SIG) at Frontier RTP. Two people were first-time attendees at ASQ Raleigh SIG events.

One of the benefits of small group in-person events is the opportunity to get to know each other, whether to meet new people or catch up with old friends. The two-hour event provided plenty of time for personal introductions and various discussion topics.

One attendee brought up the topic of “Living Quality” — a company initiative to drive a Quality Culture from a product lifecycle perspective. The quality culture topic has repeatedly come up in many meetings. “Quality is everyone’s responsibility” seems obvious but hard to realize in an organization — from the top management to the shop floor and across all functions.

What’s also interesting was that the company was in the middle of splitting into two entities, potentially involving mergers and acquisitions. Participants agreed that Quality cannot be separate from the process that creates value. Quality is not a shared service like Information Technology (IT).

As usual, in addition to quality culture, several participants talked about their jobs, customers, products, and processes involved. It’s always enlightening to learn about other businesses and see similar challenges.

One of the new attendees was a recent Ph.D. graduate in life sciences looking into Quality as a potential career path. Several participants shared their career journeys and answered the question “How did you get into Quality?” A common answer is “That wasn’t my plan when I started!” There are always plenty of personal stories to share.

The next monthly SIG meeting will be on December 19, 2025 (at the same time and location).