Quality Leaders Forum Raleigh Durham: What are your Greatest Risks in Systems Validation?

By Panos Boudouvas
on November 12, 2019

John Mandy participated in thousands of audits during his 26-year tenure as a Quality Leader at Pfizer. Early on, Pfizer had thousands of GMP suppliers and CMOs located all over the world. In any given year, Mandy’s audit teams were executing  over a thousand internal and external audits and assessments. But even he was surprised when he was helping a site prepare for a significant re-inspection and had a local QA lead proudly show him a validation qualification for a new paper shredder.  That was just one of many times that he observed teams not taking a risk-based approach to systems validation. 

What’s in a Quality Rating? Probably not enough (yet)

By Panos Boudouvas
on October 31, 2019

Janet Woodcock made headlines (again) by discussing the possibility of a quality rating system to aid transparency in her recent blog. But the devil is in the details when it comes to ratings for a site’s quality maturity.

Think A Quality Culture Doesn't Affect Your Bottom Line? Think Again

Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen.

Boston Quality Leaders Forum: Scaling Your QMS for Business Growth

By Celia Brown
on September 25, 2019

The mission of the Quality Leaders Forum (QLF) is to exchange knowledge and build a community of the best quality leaders in the life sciences industry. We will learn from one another and confront the challenges associated with compliance today – and in the future. 

To Efficiency and Beyond: Demonstrating the ROI of your eQMS

By Panos Boudouvas
on July 03, 2019

Effective  quality leaders know that securing executive support and buy-in are key factors  in successfully selecting and implementing an  eQMS. Convincing skeptical C-suite colleagues of the strategic implications and costs of  the current state can be challenging, especially in documenting both hard costs and intangible benefits/risks.   It is necessary to speak in terms that they understand and appreciate, starting with Return on Investment (ROI).