Dave Exline, President, Gateway Analytical at Gateway Analytical, an Aptar Pharma company

Why did you decide to do a webinar with us?

Leak detection testing of finished sterile containers is of such critical importance for pharma partners, that we felt it worthwhile exploring the subject in a webinar.

What will the audience gain from attending your webinar?

Leak detection, along with particulate matter defect identification, enables on-time release of drug products at each stage of the development programme, including clinical trials and commercial launch.

 This webinar will provide delegates with an overview of the USP <1207> Container Closure Integrity chapter. We will explain why the FDA now prefers deterministic leak detection methods over traditional probabilistic methods. We then review common applications of leak detection for sterile containers and present case studies on our work.

 How did you get into the industry and what do you most enjoy about your role?

I got into the industry in a very unusual way.  I was a forensic scientist specializing in fiber identification and characterization.  I was approached by a large pharmaceutical company to help solve a serious fiber contamination problem with an injectable product.  We solved the issue quickly, which led to additional investigations.  I have been doing this type of work ever since.

 What are you hoping to achieve in the future in your personal and professional life?

My professional priority is to ensure the continuous learning and improvement of our capabilities, so that Gateway Analytical is seen as the true go-to partner and thought leader in analytical services.

In my person life, I strive to help my children navigate the college experience and every day try to be a better husband and father.

 What would someone be surprised to know about you?

My early career was spent as a Forensic Scientist specializing in trace evidence analysis.  Also, I spend my free time working in the area of art and antiquities authentication.