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The 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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The Compliance Challenge of BioTech in Winter Sports
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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QSR Transition to QMSR
Compliance ► December 13, 2023

QSR Transition to QMSR

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...

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The 12 Days of Quality
Compliance ► November 30, 2023

The 12 Days of Quality

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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The Power of Strong Leadership in Quality Roles
Leadership ► October 27, 2023

The Power of Strong Leadership in Quality Roles

Celebrating Women’s Contributions In today’s dynamic and ever-evolving business landscape, quality leadership is pivotal in ensuring an organization’s success and growth. Effective leadership in quality roles not only enhances product or service quality but also...

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How a GLP Facility Can Go Digital in a Compliant Manner
Compliance ► July 10, 2023

How a GLP Facility Can Go Digital in a Compliant Manner

We recently completed a workshop on How a GLP facility can go digital in a compliant manner at a large multinational company. The 3-day workshop, led by Jackie Torfin and Brendan Hyland, started with a...

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From Meh to Magnificent! Using Situational Leadership to Improve Your Quality Culture
Leadership ► May 12, 2023

From Meh to Magnificent! Using Situational Leadership to Improve Your Quality Culture

Does this seem familiar? In a small company called Inept Inc., a well-intentioned but misguided manager named Mr. Fumble, a man with an undeniable charm that often eclipsed his incompetence, surrounded himself with a team...

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  • The Compliance Challenge of BioTech in Winter Sports
  • Bridging the ISO 13485 to QMSR Gap: The Top 3 Overlooked Issues
  • The Quality Compass: How Leadership Styles Forge a Culture of Excellence in Pharma and MedTech
  • World Quality Month: A Quality Veteran’s Reflection
  • Beyond the SOP: Why Your Leadership Style is Your Most Critical Quality Tool

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