Get Exposed – Get Harmonized: What I Learned At This Year’s SQA Conference And Quality College

I regularly attend the Society of Quality Assurance Annual Meeting #SQA2023 and Quality College #GQAC, and this year was special because we were back in person. I wanted to take a moment and reflect on the lessons that made this year special for me.

Here are the biggest takeaways:

1)?????Support Groups Rule

It’s great to be back in-person with other QA professionals. The validation you get from people when you tell them what you’re going through is huge and not to be underestimated. It’s nice to know that you’re not alone and that you’re not crazy. It’s like reuniting your support group after a long hiatus and you all just pick up where you left off as if no time has passed.

2)?????Regulators Also Like Being In Casual Situations

To their credit, SQA has worked hard over many years to have a strong regulator presence. This year, there were 21 regulators representing 10 agencies and nine countries to help the industry work together on the common goal of patient safety. Regulators come to help reinforce and review with attendees what they have seen and what their inspections have uncovered. They come willingly to answer questions.

And quality people come to learn and hear suggestions in order to gain direct feedback in a casual setting (that is, not in the middle of an inspection).

Regulators also come to listen. That is the best part of it all. Everyone is learning together. Talking and listening and learning together.

An example, I found my “Harmonizing Quality Management Systems and Training Across GxP Functions” session bookended between two FDA regulators. Why? Our topics meshed well together. The first presentation was about how FDA trains inspectors (they are hiring BTW…here’s more info on that if you’re interested.). And the final one involved the regulatory perspective on Quality Management Systems Operating in GCPs.

3)?????Putting New Tools In The Toolkit

QA professionals need to know the differences across the GXPs so they can inform our approach. Rather than operating from a “I’m going to mandate this” position, it is much better to operate from a “Tell me what you are doing, and help me understand it…and then let’s put better processes in place.” This approach can eliminate redundancy and improve compliance and efficiency, so we can accelerate the time to market of drugs product and spend less time in checkbox exercises.

There were comments made (I took notes) that offered different approaches and concepts that can help me present information in different ways that allow me to address resistance or improve how I can speak with clients if we need to put something in place and make a change. Many quality people have different perspectives, so when you hear something that resonates, you write it down and say, “I’m going to use that.”

During a GMP workshop course I taught, a woman came up to me afterwards and said, “I’m from the GCP world, and I found the information fascinating because we don’t get exposed to any of this.” She was intrigued by how terms such as “special designations” and “accelerated approval” only help clinical and regulatory and not CMC. And learning the differences between in use and shelf-life stability, was information that can help inform and improve her understanding of the process.

Can’t We All Just Get Harmonized?

Being at a conference like this with all kinds of GxP people–GLP, GCP, GMP, Pharmacovigilance–you expose yourself to different presentations and different areas. This information sharing and learning can bring us together to help harmonize quality management systems. When we have harmonized QMS that goes across all functions, people can be more efficient, effective and proactive and deliver a safer product.

I can’t wait for next year!