Articles
Connecting the dots between Quality and Business Leadership.
Lessons learned from COVID-19 is an opportunity to reduce drug
In less than a year, a COVID-19 vaccine was developed, approved, produced, and provided to people. We have a unique…

Quality Reborn
Proceedings from the conference “ICH Q9(R1): The Next Frontier, Technological University Dublin, Ireland, June 1st, 2023”

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…

Transforming Quality from a Traditional Support Function to a Strategic
Shifting Mindsets and Evolving Processes to Fully Realize Opportunities for Excellence by Implementing the Six Traits of Quality Business Leadership

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…

Industry Paradigm Shift from Compliance to Quality Investment Value Urged
A Quality Business Leadership Summit (QBL), held in Dublin, Ireland in May 2024, brought industry, regulator and academic experts together…

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

Transforming Quality Management into Quality Business Leadership: Key Takeaways from
The inaugural Quality Business Leadership Summit confirmed a need for Quality leaders in the pharmaceutical industry to transition to Quality…

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…

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…
