Paul Daniel, Sr. Regulatory Compliance Expert at Vaisala, has 17 years of validation experience in the pharmaceutical industry.
He has extensive practical grounding in applying the Good Manufacturing Practices and principles of FDA 21 CFR Parts 11, 210, 211, and 820 and specializes in authoring and executing validation protocols. He has a B.S. in biology from the University of California, Berkeley.
Why did you decide to do a webinar with Business Review Webinars?
Through webinars, we are trying to reach a wider audience, to share the vast amount of knowledge that Vaisala carries regarding measurement, and to show the application of this knowledge to the specific needs of Life Sciences businesses. At Vaisala we truly think that we can make the world a better place by helping people measure it better. In this case, we are talking about measuring temperature and humidity in the spaces that are used to store temperature sensitive drugs that will have a real-life impact on the patients and their families.
What are you looking forward to explaining to the audience?
I hope to convey how simple temperature mapping really can be. Temperature mapping is a key part of showing adherence to Good Distribution Practices (GDP) regulations. The need for this skill is increasing drastically as regulatory focus on GDP increases worldwide. The recent revision to GDP are all placing increased responsibility on the parties farther down the chain – distributors, shippers, even pharmacies. These are groups that are not familiar with mapping, and have a lot of questions about how to do it correctly. Success, in this webinar, would be showing that group of people how easy temperature mapping can be.
What do you most enjoy about your role?
I really enjoy the customer interaction. I find helping people find the answers to their questions to be very fulfilling. Everybody wins. Our customers get the answers (or at least clearer questions) to move forward with their projects, which are generally focused on improving people’s quality of life; and I get to help!
What would someone be surprised to know about you?
My initial training was in Biology. I found I didn’t really care much for the lab, and instead applied myself to some field studies. My first job out of college was catching rattlesnakes, to help some colleagues with their post-doctoral studies. It was fun, but didn’t pay well, despite the dangers. Though I returned to the lab, this time a calibration and validation lab, I often moonlighted in interesting side-jobs: I have taught wilderness survival classes, raised chickens and goats on a small farm, and manufactured hand-made wooden beer mugs.
What do you do in your leisure time to relax?
My leisure is spent hiking, playing guitar, or dog training. I am the proud owner of a French Bulldog puppy named Ruby. She is currently teaching me the true meaning of stubborn.
To view this webinar hosted by Paul Daniels and sponsored by Vaisala register here