Ah, summer—the season of sunshine, vacations, and… compliance headaches? That’s right! While you’re dreaming of beach days and ice-cold lemonade, the medical device and pharmaceutical industries are sweating over temperature spikes, staffing shortages, and supply...
Read MoreIt happens multiple times a year when I interact with pharma, biotech, or medtech clients. We start discussing computerized system use and data integrity, and inevitably, I hear some variation of: “Our electronic data is...
Read MoreAn Unpopular Opinion The recent court decision in American Clinical Laboratory Association (ACLA) v. FDA struck down the FDA’s rule regulating laboratory-developed tests (LDTs), ruling the agency lacked statutory authority. While the court was legally...
Read MoreEach year, the world dedicates a day to reflect on the incredible power of women leaders and the influence they wield. This year it was March 8th – International Women’s day. This photo, taken during...
Read MoreWhen I reflect on my career journey, one pivotal moment stands out in my memory. It was 1995—a year that would shape my professional narrative in profound ways. At the time, I held the somewhat...
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