Confessions of a Quality Queen
It’s my birthday month, and as we typically do , I have taken time to be introspective about where I have been and where I am going. From 2001 to 2020, I was the Head...
Read MoreThe Compliance Challenge of BioTech in Winter Sports
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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For Father’s Day – An Ode to Deming, the Father of Quality
Happy Father’s Day to all the wonderful fathers out there! In the world of quality management, one name stands out above the rest – Dr. W. Edwards Deming, often regarded as the “father of quality...
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The eternal enjoyment of the QMS update!
It’s 1995, and I’m ready to lead the charge in implementing ISO 13485 and the new Quality System Regulation. I am new to the quality system game, as are we all – it has been...
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Spring Cleaning, Quality Style
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,...
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Quality Training (March) Madness
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...
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Love Your Quality System: Navigating the Heart of Medical Device and Pharmaceutical Excellence
Exploring best practices for quality documentation, employee training, and internal audits of Quality Management Systems
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