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...
Read MoreExploring best practices for quality documentation, employee training, and internal audits of Quality Management Systems
Read MoreIn 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...
Read MoreCelebrating 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...
Read MoreDoes 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...
Read MoreIt’s 1995 and I am excited to be in my first team meeting, leading the implementation of not only ISO 13485, but the new Quality System Regulation! I’ve read everything I can read about what...
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