Tag Archives: Continuous Improvement

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 Meet and Greet with the Leadership Team

ASQ Raleigh Meet and Greet with the Leadership Team — February 18, 2026

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On February 18, the ASQ Raleigh Leadership team held a “meet and greet” networking session at the NC Biotech Center to welcome and engage quality professionals in the Triangle area. The attendees included long-term ASQ members and some newcomers.

One exciting addition at this meeting was the brand new ASQ Raleigh banner (see the photo) showing who we are and what we do! Thanks to our Section Chair Maria Mahrukh for designing and bringing it to the meeting.

We had almost the entire Leadership team in person at this meeting, which was incredible, given how far many had to travel from their work or home. Each member of the Leadership team, including several new Member Leaders, introduced themselves and their volunteering roles in the ASQ Raleigh Section. We celebrated what the team had accomplished in the past year and shared our ideas and plans for 2026.

After every attendee gave their introduction, we naturally gathered into small groups and got to know each other. Many of the topics discussed were centered around improving the Quality culture at the workplace, engaging members, and increasing the impact of ASQ Raleigh in the local community. As a result, many new ideas for collaboration and action came out, and the room was full of energy and enthusiasm about what’s coming in 2026.

Many thanks to our Member Leaders and to the participants!

If you are interested in Quality and Continuous Improvement, please join us in future events to learn and share your passion. Contact any of the ASQ Raleigh team if you have any questions or suggestions.

We look forward to seeing you and hearing from you!

Quality in the Triangle (QIT) Conference — October 6, 2026

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Theme: Leading with Quality

In a fast-moving world, how do you best meet the moment?

From leveraging cutting-edge technology to mastering effective communication and fostering cross-functional collaboration, professionals like you are using quality tools and insights to thrive in an ever-evolving landscape. At QIT, you can connect with quality leaders, dive into fresh ideas, and discover bold new ways to drive meaningful, measurable impact for your organization. Join us to learn how to lead with Quality!

The 2026 Quality in the Triangle conference will offer actionable strategies and deep insights into organizational excellence, new or disruptive technologies, leadership and change management, and quality fundamentals. Attendees will come away with vital tools and tactics to affect change, increase value, and drive their organizations toward quality goals. We are looking for innovative, exciting, and knowledgeable education sessions focused on quality topics and initiatives for the 2026 QIT.

Agenda and registration information will be added as they become available.

If you are interested in presenting at the conference, please read Call for Proposals and submit your proposal by April 17th.

SIG Meeting — January 8, 2026

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The first ASQ Raleigh Section open discussion meeting of 2026 was well attended, with 14 participants, several of whom were newcomers! Following the lively discussion on AI in quality at our December meeting, Chris Andrassy volunteered to lead a session on integrating AI into nonconformance investigations and reporting. We discussed his implementation in which data is collected, guided by AI, followed by AI analysis, suggested likely root causes, and report generation.

ASQ Raleigh SIG meeting
Chris Andrassy shares his thoughts

There was extensive discussion about the interaction and roles of humans and AI. While AI can provide consistency, efficiency, and sometimes insights, it can also make mistakes and requires human oversight. Is there an issue with “oversight fatigue”, where human experts don’t notice AI errors? One suggestion was to use the interaction between the AI agent and the human, in which the AI agent asks the human probing questions.

It seemed as though a similar capability could be created for change control.

It was noted that, as with other quality areas, a process needs to be established with valid data before automating it with AI. To analyze the problem and identify potential root causes, AI needs a sufficient volume of accurate historical data.

Tim Whetten

ASQ Raleigh Special Interest Group Meeting — December 10, 2026

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The Special Interest Group (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.

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 credits 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.

Registration will be available 3-4 weeks before the event.

For questions, please contact Fang Zhou at ASQRaleighSIG@gmail.com.

Pre-meeting Office Hour

If you have some questions and would like to have a one-on-one discussion or consultation with someone who has relavent knowledge and experience, you can simply stop by before the SIG meeting and talk to one of the ASQ Raleigh member volunteers who will be there 3:30 – 4:30 pm. No appointment or registration is required, and you are welcome to attend the group meeting to gain additional perspectives from other attendees. For more details, please visit our Consultation page.

ASQ Raleigh Special Interest Group Meeting — November 12, 2026

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The Special Interest Group (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.

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 credits 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.

Registration will be available 3-4 weeks before the event.

For questions, please contact Fang Zhou at ASQRaleighSIG@gmail.com.

Pre-meeting Office Hour

If you have some questions and would like to have a one-on-one discussion or consultation with someone who has relavent knowledge and experience, you can simply stop by before the SIG meeting and talk to one of the ASQ Raleigh member volunteers who will be there 3:30 – 4:30 pm. No appointment or registration is required, and you are welcome to attend the group meeting to gain additional perspectives from other attendees. For more details, please visit our Consultation page.

ASQ Raleigh Special Interest Group Meeting — October 8, 2026

,

The Special Interest Group (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.

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 credits 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.

Registration will be available 3-4 weeks before the event.

For questions, please contact Fang Zhou at ASQRaleighSIG@gmail.com.

Pre-meeting Office Hour

If you have some questions and would like to have a one-on-one discussion or consultation with someone who has relavent knowledge and experience, you can simply stop by before the SIG meeting and talk to one of the ASQ Raleigh member volunteers who will be there 3:30 – 4:30 pm. No appointment or registration is required, and you are welcome to attend the group meeting to gain additional perspectives from other attendees. For more details, please visit our Consultation page.

ASQ Raleigh Special Interest Group Meeting — September 10, 2026

,

The Special Interest Group (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.

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 credits 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.

Registration will be available 3-4 weeks before the event.

For questions, please contact Fang Zhou at ASQRaleighSIG@gmail.com.

Pre-meeting Office Hour

If you have some questions and would like to have a one-on-one discussion or consultation with someone who has relavent knowledge and experience, you can simply stop by before the SIG meeting and talk to one of the ASQ Raleigh member volunteers who will be there 3:30 – 4:30 pm. No appointment or registration is required, and you are welcome to attend the group meeting to gain additional perspectives from other attendees. For more details, please visit our Consultation page.

ASQ Raleigh Special Interest Group Meeting — August 13, 2026

,

The Special Interest Group (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.

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 credits 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.

Registration will be available 3-4 weeks before the event.

For questions, please contact Fang Zhou at ASQRaleighSIG@gmail.com.

Pre-meeting Office Hour

If you have some questions and would like to have a one-on-one discussion or consultation with someone who has relavent knowledge and experience, you can simply stop by before the SIG meeting and talk to one of the ASQ Raleigh member volunteers who will be there 3:30 – 4:30 pm. No appointment or registration is required, and you are welcome to attend the group meeting to gain additional perspectives from other attendees. For more details, please visit our Consultation page.

ASQ Raleigh Special Interest Group Meeting — July 9, 2026

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The Special Interest Group (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.

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 credits 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.

Registration will be available 3-4 weeks before the event.

For questions, please contact Fang Zhou at ASQRaleighSIG@gmail.com.

Pre-meeting Office Hour

If you have some questions and would like to have a one-on-one discussion or consultation with someone who has relavent knowledge and experience, you can simply stop by before the SIG meeting and talk to one of the ASQ Raleigh member volunteers who will be there 3:30 – 4:30 pm. No appointment or registration is required, and you are welcome to attend the group meeting to gain additional perspectives from other attendees. For more details, please visit our Consultation page.