Paul Daniel, Senior Regulatory Expert at Vaisala, has over 19 years of validation experience in the pharmaceutical and medical device industries.
Paul has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network, and computer validation, and extensive practical grounding in applying the good manufacturing practices principles of the FDA 21 CFR Parts 11, 210, 211, and 820.
An expert in authoring and executing validation protocols for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines. Paul holds a bachelor’s degree in biology (with honors) from the University of California, Berkeley.
What is your favourite thing about presenting on webinars?
It is an opportunity for me to give something back to the professional Life Science community which has given me a rewarding career in Validation.
What are you looking forward to explaining to the audience?
Mean Kinetic Temperature (MKT) is a really interesting topic. There is a deep and engaging story in the history of MKT that is intertwined with the history of HVAC and monitoring technology, and heavily influenced by ongoing regulatory changes in Good Distribution Practice. I am looking forward to sharing this story, so that we can see how our understanding and use of MKT has changed over the last 40 years, and hopefully, have a better idea of where this unique tool can be used effectively today.
What attracted you to the industry and what do you enjoy most about working at VAISALA?
I became involved in Pharmaceutical Validation because I was good with details, and I was seeking an industry where my work would have a direct link to improving quality of life. I joined Vaisala over 4 years ago because I thought it would allow me to be more effective at influencing positive change within my industry. I really like Vaisala because this company is dedicated to making the world a better place, one measurement at a time. Our mission statement – Observations for a Better World – conveys this idea. And, I really enjoy working with excellent people, in an established international company, that continues to create technology that changes the world. I may work in the narrow niche of Temperature Monitoring for Pharmaceuticals and Medical Devices, but Vaisala is involved in a much wider scope of enterprise that includes weather, road safety, interplanetary exploration, and preserving cultural treasures. I can’t imagine a more exciting place to work!
What is your favourite holiday destination?
I don’t have a favourite. But if you gave me two-weeks off and an expense account, there are a few places you would likely find me; high in the Colorado mountains fly-fishing an isolated stream, riding a mountain bike on remote single-track trails in the Pyrenees, or asleep in the sun on a beach in Mexico.
How did you spend the Easter holiday?
Easter was spent with friends and family, enjoying the return of spring, sitting in the sun, and talking about our hopes for the coming year.
Join Vaisala’s webinar with Paul on “Mean Kinetic Temperature in GxP Environments”. Register here.