Jackie Torfin
Why the FDA’s LDT Rule Was Necessary—Even If the Court Disagreed
An 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...
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International Women’s Day – This One’s for the Girls!
Each 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...
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From Team Member to Team Leader: Navigating the Challenges of Management
When 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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Training Effectiveness vs. Training Competence: Understanding the Nuances
How do you discern between two critical concepts within the realm of training: training effectiveness and training competence? While both are vital for optimizing performance, they address different aspects of the training process. Understanding the...
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Embracing the Slow Down: Re-Energizing at Year’s End as a Quality Assurance (QA) Professional
As the year winds down, many of us find ourselves swept up in the holiday hustle and the push to meet year-end goals. For QA professionals in the medical devices and pharmaceuticals sectors, this period...
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