Jackie has over 30 years experience and deep expertise in quality, regulatory, pre-clinical and clinical compliance. She has served in Senior Global roles for companies including Beckman Coulter, NAMSA, CIMA Labs, PDL BioPharma, Arizant/3M, and Heraeus.
It’s my 60th birthday. For many, this is a time to slow down, to look back, and to maybe even relax. But if you know me, you know that’s not quite my style. Yes, I...
A Father’s Day reflection on ribs, risk, and raising a quality leader My father could break down a side of beef before most people had finished their morning coffee. He was a butcher, a craftsman...
In medical devices and pharmaceuticals, we talk a lot about quality systems, CAPAs, and regulatory compliance. But after thirty-five years in this industry, from the clinical lab to the boardroom, I’ve realized that the most...
As of February 2, 2026, the medical device industry officially entered a new regulatory era. The long-anticipated transition is complete: the Quality Management System Regulation (QMSR) has modernized 21 CFR Part 820 by integrating ISO...
In medical devices and pharmaceuticals, quality isn’t just a department; it’s the foundation of patient safety and organizational trust. For over thirty-five years, my work from the clinical lab to the boardroom has taught me...
As we watch athletes compete in the Winter Olympics, from Alpine skiing to bobsledding, the line between peak performance and physical risk is small. In 2026, technology is not just a training aid; it’s now a...
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