Highlights from the Annual SQA Fall Symposium

posted on September 25th 2014 in News & Events with 0 Comments /


What a great week in Denver!  I started the week co-chairing the annual Fall Symposium. This year it was a combined effort between the Rocky Mountain SQA local chapter and the Regulatory Forum Council (RFC).  My co-chair, Chris Both, President of the Rocky Mountain Chapter, and myself representing RFC had a two day program focused on Root Cause Analysis across the GxPs.

The faculty provided insightful information through case studies, tool exercises, and discussions based on attendee’s questions.  A highlight was a session provided by local representatives of the Environmental Protection Agency (EPA) who provided insights to their current audit program.

A few key takeaways for me from the SQA Fall Symposium include:

  • Performing a root cause analysis is fine, but if you don’t follow through on the CAPA it doesn’t solve anything.
  • Industry needs to come up with a way to define and manage CAPA effectiveness. The  Beyond Compliance Specialty Section (BCSS) is putting together a sub-committee to submit an abstract on this topic for next year’s annual meeting.
  • Training, or re-training, is not always the answer! Look at the process to see if that needs to be changed or updated. Or does your training method need to change?

In the middle of the week, I had the pleasure to chair two days of GCP training. The Basics and Beyond the Basics sessions provided two days of great discussion and content. I learn so much from attendees every time I teach one of these classes!

A few key takeaways from the CGP training are:

  • It is always good to revisit the fundamentals!
  • Challenges are present when you deal with eTMF vs. paper TMF or a hybrid. Challenges to manage with an eTMF include access, quality of scans, ability to distinguish colorization vs. black and white, and mislabeled or misfiled documents.
  • Will informed consent eventually be an electronic process? Great discussion around the management of changes to the ICF during a trial and when patients may need to sign the updated ICF.

 Ending the week was the Train the Trainer session intended to provide QA Professionals with soft skills training.

A key takeaway for me from the Train the Trainer session is:

  • QA professionals play a pivotal role with investigators, sites, and internal departments, and in this role it’s important to have strong soft skills to keep clinical trials on track.

The BCSS is charged to provide these types of programs to the SQA membership, and there will be another session focused on soft skills training at next year’s Quality College events.

In between all of this, I got a chance to enjoy the restaurants, shops and friendly people of Denver. A true sports fan, I got to watch the Denver Broncos game with some local fans and even had a chance to take in two Colorado Rockies baseball games!

It is always good to have the opportunity to collaborate with my SQA peers. I’m looking forward to the next SQA Annual Meeting and Quality College in Tampa, Florida in April 2015.

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