Ever thought about who keeps the heroes (and sometimes villains) in check in your favorite action movies? That’s right—the fixer, the problem-solver, the behind-the-scenes mastermind helping to ensure everything goes according to plan. In the...
Hey, the days are growing longer, and the weather is warming up! It’s time to start thinking about spring cleaning our homes—a fresh start and a declutter! What if we applied this to our work,...
Maintaining a culture of quality and regulatory compliance is necessary in pharmaceuticals and medical devices. The consequences impact patient safety and organizational reputation and may have legal ramifications. So ongoing training is important, often bordering...
As we usher in the promise of a new year, the field of quality compliance in medical devices and pharmaceuticals stands at the precipice of innovation, challenges, and boundless possibilities. To seize the opportunities ahead,...
In early 2022, the US Food and Drug Administration (FDA) issued its proposed rule for medical devices, the Quality Management System Regulation (QMSR). This proposed rule connects and aligns 21 CFR Part 820 Quality System...
Deck the halls with boughs of…quality? That’s right! The holiday season is upon us, and while we’re busy spreading cheer and joy, let’s not forget to celebrate the unsung heroes of our industry – Quality...
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