How did you hear about PDA and why did you join?
I joined PDA in 2015. I was introduced initially by a colleague with whom I collaborated with on presentations for PDA conferences. The conference vibe hooked me immediately—the interactions with regulators and industry leaders, the sessions and the overall fellowship. All of this offered a link to staying current on the side of progress.
What are some of the volunteer projects you have been involved with?
I have been fortunate to serve on the PDA task force collaborating on technical reports addressing data integrity within laboratories, manufacturing and the quality management system. The team has been highly engaged, supportive and draws from diverse experiences.
What challenges do you see facing the industry?
The sweeping impact of big data and artificial intelligence has completely disrupted the data integrity regulatory paradigm, which is my area of expertise. I am fascinated and intrigued by this technology, and, equally so by all the collaborative work to define regulations, including data integrity requirements.
Who is your personal hero?
My father was a veteran. He was fierce on integrity. Character was everything. He was genteel but demanding of goodness, courage, humility and trust. If I fell short, he never raised his voice but would get a look of disappointment that could crush an army. A day does not go by that I do not reflect and draw upon his teachings.
What has been your once-in-a-lifetime experience?
When I was 38, I took a year off from my career and essentially went to live on an ashram. To partake in the community you must also serve, so I was the head of the kitchen. For the first six weeks I practiced Ashtanga yoga, meditated and studied Sanskrit from 4 a.m. to 9 p.m. I also cooked breakfast, lunch and dinner for the community in between programs.
The ashram received guests from all over the world, and for the remainder of the year, I taught yoga and cooked meals for these amazing people. Everyone was seeking mindfulness and working to align themselves with the principles of absolute love. It was a total awakening for me.