In Pursuit of The Promise of ICH Q10
"In Pursuit of the Promise of ICH Q10" argues that the pharmaceutical industry's quality systems have been reduced to compliance-only…
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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.
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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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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Are your After Action Reviews improving performance?
Free Guide + ToolkitExplore the AAR Practical Guide + Toolkit—practical resources developed with 100+ industry contributors to help Quality teams turn AARs into meaningful learning and improvement.