VAR for Pharmaceutical Inspections?
The PQS has become a compliance system driven by fear, not learning. Anders Vinther proposes a VAR-style review process for…
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Leadership Library
A collection of insights, research and commentary for those seeking a deeper understanding of Quality Business Leadership. The resources here explore how quality business leadership operates in practice, from decision-making and risk to value, trust, and performance.
The Quality Business Leadership Manifesto
Quality leadership in the pharmaceutical industry is at a turning point. The opportunity now is to move quality from a…
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Time to Retire “Cost of Quality”
How the Quality Value Index (QVI) and Financial Risk Number (FRN) shift the focus from cost-driven compliance to value-driven business…
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Industry Paradigm Shift from Compliance to Quality Investment Value Urged at Dublin Summit
A Quality Business Leadership Summit (QBL), held in Dublin, Ireland in May 2024, brought industry, regulator and academic experts together…
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Transforming Quality from a Traditional Support Function to a Strategic Business Partner
Shifting Mindsets and Evolving Processes to Fully Realize Opportunities for Excellence by Implementing the Six Traits of Quality Business Leadership
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Janet Woodcock pushing industry to adopt quality mindset
Former FDA leader teaming up with industry veteran Anders Vinther to solicit CEO support, train operations staff
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Taking a Stand for Pharmaceutical Quality: The Rise of the Quality Business Leader
A call to take a stand and commit to transforming the pharmaceutical industry.
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Transforming Quality Management into Quality Business Leadership: Key Takeaways from the First QBL Summit
The inaugural Quality Business Leadership Summit confirmed a need for Quality leaders in the pharmaceutical industry to transition to Quality…
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A Survey of 16 Key Quality Maturity Metrics
The results of the 16 question survey sent out prior to the Inaugural Quality Business Leadership Summit in Dublin May…
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Lessons Pharma Industry Can Still Learn From Deming
Deming's teachings are still highly relevant today. He is known as one of the greatest quality thinkers and quality business…
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Sustainable Compliance is Spelled with 4Cs
Quality Business Leaders must visibly demonstrate responsibility for quality. However, focusing on compliance only is setting the bar very low….
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Lessons learned from COVID-19 is an opportunity to reduce drug shortages
In less than a year, a COVID-19 vaccine was developed, approved, produced, and provided to people. We have a unique…
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3 behaviors that great Quality Business Leaders have mastered
Engaging employees is important because it takes everyone to produce a good batch and only one persons mistake to cause…
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Quality Business Leaders visibly demonstrate responsibility for quality
In this article I have described the importance of not treating the pharmaceutical companies as one and the need to…
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Quality Reborn
Proceedings from the conference “ICH Q9(R1): The Next Frontier, Technological University Dublin, Ireland, June 1st, 2023”
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