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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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 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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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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