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60 and Still a Queen: Reflections on a Life in Quality

It’s my 60th birthday. For many, this is a time to slow down, to look back, and to maybe even relax. But if you know me, you know that’s not quite my style. Yes, I...

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60 and Still a Queen: Reflections on a Life in Quality
For Father’s Day – An Ode to Deming, the Father of Quality
Quality ► June 13, 2024

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!
Musings ► May 9, 2024

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
Quality ► April 16, 2024

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
Quality ► March 6, 2024

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
Quality ► February 6, 2024

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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7 Tips for Success in 2024
Tips & Advice ► January 10, 2024

7 Tips for Success in 2024

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,...

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  • 60 and Still a Queen: Reflections on a Life in Quality
  • The Best Lessons I Ever Learned Came From a Man With a Meat Cleaver
  • The First Quality Leader I Ever Knew: Lessons from Mom
  • The FDA’s New Playbook: Preparing for Inspections Under the QMSR
  • Why Being a Woman Quality Leader in MedTech & Pharma is a Superpower

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