Tag Archives: Life Sciences

SIG Meeting – July 9, 2026

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At our monthly ASQ Raleigh Special Interest Group (SIG) meeting at Frontier RTP, we had 8 people attend, two of whom were newcomers. As we find occasionally, these two were in the process of finding new employment opportunities in the Triangle Area. One is new to the area (welcome!) and one is a victim of layoffs at Asensus Surgical.

Asensus Surgical announced layoffs of 108 employees last month and canceled the development of two products being developed in the Triangle. Asensus Surgical was purchased by Karl Storz in 2024. We talked about a the current difficulty of finding new jobs in the area and how impersonal the job search process seems now. We discussed how people have used the monthly SIG meeting to make connections that lead to new jobs and networking opportunities within the ASQ Raleigh Section.

Our next SIG meeting will be from 4:30 to 6:30 on August 13th, 2026, at Frontier RTP. We will have a short demonstration of an app that can be used to easily and flexibly create forms which can be used in internal and external audits, supplier ranking, prosses changes, etc. The announcement and registration is here!

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 — December 11, 2025

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The last Special Interest Group (SIG) meeting of 2025 welcomed three first-timers, among the eight attendees. One of them was preparing for his ASQ Six Sigma Green Belt (GB) certification and was interested in joining ASQ.

One of the attendees was a leader of a service provider using artificial intelligence (AI) to help their pharmaceutical clients in the quality and compliance area. He shared with us some of the work they did to automate tasks, reduce errors, and improve consistency.

Unsurprisingly, the topic of AI triggered many questions and responses among attendees. For example

  • Where do we see the most improvement when AI automates the tasks?
  • How much do we improve the the process before implementing AI or automation?
  • How do the AI models or tools integrate with the existing Quality Management Systems (QMS)?
  • How do we address regulatory or compliance concerns related to AI implementation?

Another attendee shared their experience using AI to process large amounts of literature and documents that humans just could not handle. But with AI, human experts only have to review a select subset of documents or a summary of the information. It sounded like many organizations have started experimenting with AI to evaluate its effectiveness and potential issues.

One of the concerns was people’s ability to learn and adapt to new technology vs. the speed of technological advance.

  • Who are responsible for keeping up with the change?
  • How much do employees have to learn on their own vs. training provided by employers?
  • How can the educational system, such as universities, prepare students for the future?

There was a general consensus among the participants that data integrity training provided by employers was insufficient and junior employees might not have the opportunity to build experience or critical thinking if AI was widely implemented.

The interest and discussion about AI will certainly continue in future meetings. So join us in 2026 at our monthly SIG meetings on the second Thursday at Frontier RTP.

Happy Holidays!

ASQ Women in Quality (WIQ) and ISPE Women in Pharma (WIP) Joint Panel Discussion

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Title: Breaking Down Silos Between Quality and Pharma Teams: Driving Innovation, efficiency, and Better Patient Outcomes

In this panel session, five industry leaders, Shelley Preslar, Katie Ray, Jennifer Popovich, Renata Marques, Lisa Evans, will share real-world insights on how strong leadership, clear communication, and shared goals foster collaboration, enhance compliance, and deliver transformative results.

WIQ SIG Panel Jan 2026

 

Registration includes light appetizers and two drink tickets.

Agenda:

  • 5:30PM: Registration
  • 6-7PM: Panel
  • 7-8PM: Networking

Contact Information: Please reach out to Ashley Norris with any questions. Email: ashleynorris@projectfarma.com

ASQ Raleigh Life Sciences SIG meeting

Life Sciences SIG — November 2025

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ASQ Raleigh held its last Life Sciences Special Interest Group (SIG) meeting of 2025 at the NC Biotech Center on the evening of November 19, 2025. We had thirteen attendees representing a range of professional backgrounds, including a recent graduate, seasoned Quality professionals, and industry consultants. Four were first-time attendees of our SIG events.

Our speaker, Nathan Blazei, is an experienced life sciences leader with a background in Quality and Regulatory Affairs. He presented his perspectives on Quality 4.0, titled “Unlocking Efficiency, Consistency, and Insight: Potential Use Cases for Artificial Intelligence in Quality Assurance.”

After a brief introduction to Quality 4.0 and associated technology, Nathan presented three potential use cases and led the discussion beyond these applications.

  • Event investigation
  • Procedure creation
  • Inspections

A common theme of the applications is automation and artificial intelligence (AI) tool’s ability to process large amounts of data. Generative AI tools can also help summarize the information from diverse data sources and answer queries quickly, saving time and improving performance.

Participants recognized that while promising, most AI systems and tools were new and in development, and few had been tested or validated in the real world. To be truly useful, the AI systems have to be integrated with the business and be trained with domain-specific data.

The fact that many AI tools are “black box” solutions was also a concern — how much can we trust the information or answers? Can we interpret it? How do we validate it? Participants seemed to agree that the tools are useful for generating the initial documents, solutions, or recommendations, which can be a time-saver, but human experts still have to fill the gaps and make the final decisions.

Despite concerns about limitations of the current technology, the participants were enthusiastic about its potential applications in Quality and Continuous Improvement, bringing up many ideas on their wish lists: pulling knowledge embedded in the organization, performing root cause analysis, creating video-based Standard Operating Procedures (SOPs), integrating skills from different experts, AI-assisted procedures, etc.

We would have continued our discussion beyond the two hours if the building security didn’t ring the bell. More is to come next year, so check our events calendar often.

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).

ASQ Raleigh Life Sciences Special Interest Group Meeting — November 19, 2025

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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: Unlocking Efficiency, Consistency, and Insight: Potential Use Cases for Artificial Intelligence in Quality Assurance

Abstract:

As regulated manufacturing operations embrace modern digital tools and advanced analytics, Quality Assurance (QA) faces mounting pressure to manage greater complexity and faster decision cycles. Artificial intelligence (AI) offers powerful tools to meet these challenges by enhancing efficiency, consistency, and insight across the quality landscape.

This collaborative discussion explores practical use cases where AI tools can be deployed to deliver value in QA. By connecting these applications under the broader framework of Quality 4.0, this session will illustrate how AI can shift QA from a reactive, compliance-focused role to a proactive, data-informed partner in manufacturing excellence.

Attendees will have the opportunity to share how AI tools may be gaining traction within their own QA organizations to provide real-world examples that may resonate with the entire group.

Presenter: Nathan Blazei, ASQ-CQA, RAC-US, Senior Director, Strategic Solutions at Kymanox

Bio:

Nathan is a versatile life sciences professional with nearly 25 years of experience across biopharmaceuticals, medical devices, and combination products in individual contributor and leadership roles. He has experience working for start-ups and global manufacturers, as well as in professional services/consulting. He is passionate about commercializing safe and effective products that will improve the quality of life for patients and their caregivers.

Nathan’s career foundation began in engineering, product and process development, manufacturing, continuous improvement, and program management roles. Over time, he made a transition to focus on quality and regulatory compliance to complement his technical experience. At the intersection of these disciplines is where he has found success over the years, as he can provide solutions that are not only technically sound, but also compliant with evolving regulatory requirements and at the leading edge of industry best practices.

Nathan acquired the Certified Quality Auditor (CQA) designation through the American Society for Quality (ASQ) and hold a Regulatory Affairs Certification (RAC-US) through the Regulatory Affairs Professionals Society (RAPS). Additionally, he is currently a Board Member for the Parenteral Drug Association (PDA), Southeast Chapter. Nathan has presented at domestic and international industry events on various topics relevant to the life sciences to share best practices, lessons learned, and new approaches to solving problems.

 

Register here.

ASQ Raleigh SIG meeting

SIG meeting — October 9, 2025

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On October 9, 2025, a small group of six people attended ASQ Raleigh’s monthly Special Interest Group (SIG) meeting at Frontier RTP. One person was a first-time attendee and non-member, who has many years of experience in Quality and was interested in joining ASQ.

Alexia Storey led the discussion around Change Control with a number of real-world questions and scenarios. A key question was “how much do we want a robust Change Control process versus people who have the competency to perform a change control effectively?”

A benefit of having a small group is that everyone has more opportunity to contribute to the discussion. The participants brought up their questions and perspectives. Overall, many questions were related to impact assessment, risk management, and roles & responsibilities of the quality manager and various stakeholders, including the Change Control Review Board or Committee.

One of the scenarios was about changes allowed after the initial approval — how much flexibility do we have during implementation without going through another change control? How much feasibility study and impact assessment should be done before approval and how much unspecified change or risk is expected? Some participants shared the practice of using amendments to address additional changes.

Another key point of discussion was defining and evaluating the change effectiveness. This will help us ensure that the implementation does what we intended to accomplish with the change.

The next monthly SIG meeting will be on November 13, 2025.

ASQ Raleigh Life Sciences Special Interest Group Meeting — May 20, 2025

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

Title: The crucial role of The Clinical Quality Management Plan (CQMP) in establishing site-based protocol integrity

Presenter: Dr Alan Touch

Summary:

The Clinical Quality Management Plan (CQMP) for clinical trials is a structured approach to ensuring the integrity, reliability, and compliance of clinical research at the site level. It is core to maintaining Good Clinical Practice (GCP)standards and regulatory requirements throughout the trial process.

CQMP establishes the quality management guidelines for tasks related to the Sponsor, CRO and Study Site for responsibilities for a defined Clinical Trial Protocol. This plan is normally the responsibility of the Sponsor Quality Assurance department although its development and implementation can be facilitated by a Quality and GCP Audit Partner.

This presentation will delineate the critical role of CGMP in GCP, a delineation of the actual types of content for a CGMP, the steps to the development of the CQMP and the effect the 21st Century Cures Act on these responsibilities and current US FDA expectations regarding site responsibility for clinical trial protocol data integrity.

Who Should Attend:

  • Quality and Clinical Development personnel
  • Regulatory personnel
  • Clinical trial project managers
  • Site study personnel
  • Site Management Organization administrators

 

Register here.