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# Quality Business Administration

## Sitemaps
[XML Sitemap](https://qbaleaders.com/sitemap_index.xml): Includes all crawlable and indexable pages.

## Posts
- [In Pursuit of The Promise of ICH Q10](https://qbaleaders.com/articles/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 tools, and calls for a systems-thinking-driven, multi-stakeholder effort to unlock their full potential for continual improvement, drug availability, and patient outcomes.
- [VAR for Pharmaceutical Inspections?](https://qbaleaders.com/articles/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 outlier inspection observations — and a broader conversation about what the system should actually do.
- [The Quality Business Leadership Manifesto](https://qbaleaders.com/articles/the-qbl-manifesto/): Quality leadership in the pharmaceutical industry is at a turning point. The opportunity now is to move quality from a support function to a strategic driver of value. This is the moment for the Quality Business Leader.
- [Time to Retire “Cost of Quality”](https://qbaleaders.com/articles/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 performance, helping pharmaceutical companies align quality with financial goals.
- [Industry Paradigm Shift from Compliance to Quality Investment Value Urged at Dublin Summit](https://qbaleaders.com/articles/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 to explore how to shift pharma from mere compliance to a quality investment mindset—one that drives innovation, boosts financial performance, and strengthens supply-chain resilience.
- [Transforming Quality from a Traditional Support Function to a Strategic Business Partner](https://qbaleaders.com/articles/transforming-quality-from-traditional-support-function/): Shifting Mindsets and Evolving Processes to Fully Realize Opportunities for Excellence by Implementing the Six Traits of Quality Business Leadership
- [Janet Woodcock pushing industry to adopt quality mindset](https://qbaleaders.com/articles/janet-woodcock-pushing-industry/): Former FDA leader teaming up with industry veteran Anders Vinther to solicit CEO support, train operations staff
- [Taking a Stand for Pharmaceutical Quality: The Rise of the Quality Business Leader](https://qbaleaders.com/articles/the-rise-of-the-quality-business-leader/): A call to take a stand and commit to transforming the pharmaceutical industry.
- [Transforming Quality Management into Quality Business Leadership: Key Takeaways from the First QBL Summit](https://qbaleaders.com/articles/first-qbl-summit-key-takeaways/): The inaugural Quality Business Leadership Summit confirmed a need for Quality leaders in the pharmaceutical industry to transition to Quality Business Leadership
- [A Survey of 16 Key Quality Maturity Metrics](https://qbaleaders.com/articles/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 2024 are shown and discussed in this article.
- [Lessons Pharma Industry Can Still Learn From Deming](https://qbaleaders.com/articles/pharma-industry-lessons-from-deming/): Deming's teachings are still highly relevant today. He is known as one of the greatest quality thinkers and quality business leaders over the last century. His teachings applied transformed the Japanese car industry as a very well know example. Deming published his System of profound knowledge which included his 14 points of management. 
- [Sustainable Compliance is Spelled with 4Cs](https://qbaleaders.com/articles/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. In this article I describe the importance of culture, competencies and capacity to get to a more sustainable compliance
- [Lessons learned from COVID-19 is an opportunity to reduce drug shortages](https://qbaleaders.com/articles/lessons-learned-from-covid-19/): In less than a year, a COVID-19 vaccine was developed, approved, produced, and provided to people. We have a unique opportunity to retire the old system for managing PACs and replace it with a new agile and patient centric approach built on lessons learned from the global pandemic response.
- [3 behaviors that great Quality Business Leaders have mastered](https://qbaleaders.com/articles/3-behaviors-great-quality-business-leaders/): Engaging employees is important because it takes everyone to produce a good batch and only one persons mistake to cause the batch to fail. Engaging employees can be difficult in a highly regulated environment where following procedures is critical.
Often making a decision can be difficult balancing both benefits and risks to patients, compliance and the business. Here I discuss some of the things to consider.
As Quality professionals we tend to speak in compliance jargon which can be difficult to understand outside compliance. We need to be speaking both cGMP and $GMP
- [Quality Business Leaders visibly demonstrate responsibility for quality](https://qbaleaders.com/articles/quality-leaders-demonstrate-responsibility-for-quality/): In this article I have described the importance of not treating the pharmaceutical companies as one and the need to differentiate the flexibility that is given to companies by regulatory agencies based on quality performance. Warning Letters issued by FDA often demonstrate the failure of the Quality Function and Company Senior Management to fulfill their role. As a community of Quality leaders we need to address shortcomings in our industry to increase confidence.
- [Quality Reborn](https://qbaleaders.com/articles/quality-reborn/): Proceedings from the conference “ICH Q9(R1): The Next Frontier, Technological University Dublin, Ireland, June 1st, 2023”

## Pages
- [Faculty](https://qbaleaders.com/qbl-faculty/)
- [Business Overview](https://qbaleaders.com/ai-business-overview/)
- [Certification](https://qbaleaders.com/certificate-in-quality-business-leadership/)
- [Press and Media](https://qbaleaders.com/press-and-media/)
- [Quality Maturity Score](https://qbaleaders.com/qba-quality-maturity-score/)
- [Articles](https://qbaleaders.com/articles/)
- [6 Quality Business Leadership Traits](https://qbaleaders.com/6-quality-business-leadership-traits/)
- [QBA Newsletter](https://qbaleaders.com/qba-newsletter/)
- [Home](https://qbaleaders.com/)
- [Contact](https://qbaleaders.com/contact/)
- [About](https://qbaleaders.com/about/)

## Program Outline
- [Week 10 – Lead The Path To One Regulatory Framework](https://qbaleaders.com/program-outline/week-10/): Recap and Next Steps
- [Week 09 – Risk-Informed Decisions](https://qbaleaders.com/program-outline/week-9/): Decision Making 2 Decision making case studies 2, communication of difficult decisions to authorities Working with regulatory authorities when good and when bad message
- [Week 08 – Risk-Informed Decisions](https://qbaleaders.com/program-outline/week-8/): Decision Making 1 Quality decision making authority, challenges in decision making QR9(R1), RBDM, decision making models, benefit/risk patient centric Decision making and prioritization, case studies 1
- [Week 07 – Quality Owned by All](https://qbaleaders.com/program-outline/week-7/)
- [Week 05 – Culture and Engagement](https://qbaleaders.com/program-outline/week-5/)
- [Week 04 – Visibly Demonstrate Responsibility for Quality](https://qbaleaders.com/program-outline/week-4/)
- [Week 03 – Promote Quality As A Value-Driven Financial Advantage](https://qbaleaders.com/program-outline/week-3/): This week we continue with the trait promote quality as a value-driven financial advantage.
- [Week 02 – Promote Quality As A Value-Driven Financial Advantage](https://qbaleaders.com/program-outline/week-2/): This week we start talking about the trait promote quality as a value-driven financial advantage. We cover financial statements, cost management, linking quality to financial performance, Quality Value Index (QVI) models, and introduce Financial Risk Numbers (FRN).
- [Week 01 – Taking a Stand for Pharmaceutical Quality; Introduction to QBL](https://qbaleaders.com/program-outline/week-1/): Course introduction and overview / Introduction to Facilitators / Expectations Why we need Quality Business Leadership Introduction to six traits of QBL & the transition needed Quality Operating in headwinds. Quality’s role and focus today
- [Week 06 – Culture and Engagement](https://qbaleaders.com/program-outline/week-6/)

## Services
- [In House Workshops](https://qbaleaders.com/services/in-house-workshops/)
- [Consulting](https://qbaleaders.com/services/consulting/)
- [Private Business Coaching](https://qbaleaders.com/services/coaching/)
- [QBA Certification](https://qbaleaders.com/services/qba-certification/)
- [Quality Maturity Score](https://qbaleaders.com/services/quality-maturity-score%ef%b8%8f/)

## Testimonials
- [Wilian Silveira](https://qbaleaders.com/testimonials/wilian-silveira-2/)
- [Wilian Silveira](https://qbaleaders.com/testimonials/wilian-silveira/)
- [Pat Hancock](https://qbaleaders.com/testimonials/pat-hancock-3/)
- [Pat Hancock](https://qbaleaders.com/testimonials/pat-hancock-2/)