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...
Read More
The FDA’s new Quality Management System Regulation (QMSR) takes effect February 2, 2026, harmonizing with ISO 13485. This shifts the framework from the old, prescriptive QSR to a more proactive, process-based system rooted in risk-management....
Read MoreIn pharmaceuticals and medical devices, “quality” is more than a department, it’s the core of the industry. It’s the difference between a life-saving drug and a catastrophic recall, between a trusted medical implant and a...
Read MoreIt’s World Quality Month, and for those of us in Quality, it’s an interesting annual event. Our work, if we’re doing it well, is meant to be invisible. When we do our jobs perfectly, nothing...
Read MoreIn medical device and pharmaceutical manufacturing, we pride ourselves on precision. Our processes are validated, our Standard Operating Procedures (SOPs) are detailed, and our quality systems are designed to eliminate variability. Yet, despite these robust...
Read MoreFor four years now, I have paused around this date to share this story. I do it not for sympathy, but for fidelity, a conscious decision to defy the silence that time imposes. Life often...
Read MoreChange is inevitable—but successful change is an art. As a seasoned change agent, I’ve led numerous initiatives, from Quality Management System overhauls to M&A integrations. I’ve studied the theories, applied the models, and navigated the...
Read More
