Monthly Archives: May 2025

ASQ Raleigh Special Interest Group Meeting

Life Sciences SIG — May 2025

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ASQ Raleigh had its second Life Sciences Special Interest Group (SIG) meeting of the year on May 20 at the NC Biotech Center. Dr. Alan Touch gave a presentation titled “THE CLINICAL QUALITY MANAGEMENT PLAN — GCP Clinical Trial Site Compliance Mandatory to Study Data Integrity.”

Fifteen people, including non-members, attended the meeting and participated in networking and discussion. During the introduction, Dr. Touch emphasized how much clinical studies and patients count on the Quality professionals to ensure safety and integrity.

Dr. Touch first covered the key concepts, including

  • The GCP framework and ICH E6 R3
  • What’s the Clinical Quality Management Plan (CQMP)
  • Key components of CQMP
  • Site considerations
  • Typical content of a CQMP template

To help illustrate the critical role of a CQMP, Dr. Touch shared a case study in which highly respected medical sites failed in several aspects in the GCP audit when no CQMP was in place. The example led to a number of questions and comments from the audience, for example

  • the roles and responsibilities of the sponsors, Contract Research Organizations (CROs), and medical sites in developing and implementing the CQMP
  • the role of the Quality functions
  • how to evaluate and select sites

If you are interested in clinical quality management or related topics, please let us know.

Photo of ASQ Raleigh SIG meeting attendees

SIG Meeting — May 2025

Event, SIG, ,

On May 8th, nine people gathered at Frontier RTP for our monthly Special Interest Group (SIG) meeting. Again, we had some regular attendees and welcomed new ones, including a non-member.

The attendees represented mostly the life sciences industry but shared prior experience in other industries, such as automotive. It’s always interesting to hear the similarities and differences between industries in terms of quality management practices, challenges, and terminology used.

One discussion point was related to customer complaints — how do we handle them effectively, who are responsible, what actions do they trigger, etc.? Having the right or sufficient information from the end users is critical but often lacking, making understanding the symptoms and identifying root causes difficult.

One attendee was looking for a job in Quality and received many helpful suggestions from the others, including the type of jobs to start with, e.g. Quality Control, and the ASQ certifications available. The in-person events like this really help people connect and build a network. If you are interested in or new to the profession, please join us and learn more from people who have worked in Quality for decades!

The next SIG meeting at Frontier RTP will be on June 12, 2025.