In medical devices and pharmaceuticals, we talk a lot about quality systems, CAPAs, and regulatory compliance. But after thirty-five years in this industry, from the clinical lab to the boardroom, I’ve realized that the most...
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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...
Read MoreWe 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...
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 MoreI “DO” change leadership. I am a proud change agent. I have led many change initiatives, from Quality Management System updates to Merger and Acquisition teams. I have read the change theories, studied the books,...
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...
Read MoreA warning letter published on July 19th, 2022 by the FDA to Young Living Essential Oils names not only the company but also individual consultants within its multi-level marketing organization (find it below). The FDA...
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