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.

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