Friday, 13 July 2018Kari Miller, Regulatory & Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
With the pace at which business moves today, we’re not often provided the opportunity to revisit previous blog posts, reflect back on position statements, or re-examine our thoughts from a fresh perspective. However, recently an e-book that I authored two years ago, Finding Your Path to Quality Nirvana
, was re-published, giving me the opportunity to reassess some of the questions that were posed within its pages.
In the e-book, I answered the following questions, and I wondered, now that time has passed, what came to be, and how some of the questions would be answered today.
Friday, 06 July 2018Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIA
The quality, regulatory, safety, and commercial compliance management areas are quite often looked at as organizational necessities rather than value-added functions. They also are areas that sometimes lack innovation and transformation.
In a recent global survey of pharmaceutical CEOs, regulatory concerns continue to be viewed as a threat to growth. In fact, since 2013, these concerns, collectively, are among the top three threats as reported by pharma executives (PWC’s 20th Annual Global Pharma CEO Survey)
Tuesday, 03 July 2018Marla Kessler, Senior Vice President, Strategy, Marketing, and Communications, IQVIA
It’s an exciting time in healthcare. We now live in a world of bionic eyes and pills made from 3D printing. We are seeing technology advance health every day providing a glimpse of the potential ahead of us. Sharing this vision, we at IQVIA are exploring a new discipline – Human Data Science – to bring together the advances in data science with the possibilities of human science to improve health.
Friday, 29 June 2018Bernard Jee, Product Manager, Pilgrim Quality Solutions, an IQVIA company
You’re probably conducting incoming inspections today but if you aren't taking a risk-based approach, chances are you’re performing inspections you don’t need to do and possibly overlooking the items which need to be inspected most. Implementing a risk-based sampling system helps you spend less time and less money inspecting high-quality raw materials when you are already confident that they are good. You’re also able to pinpoint poorly performing raw materials and suppliers based on their inspection state.
Tuesday, 19 June 2018Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
More than ever before, Life Science quality professionals are feeling the pressure of increasing regulations and the rapid pace of business and industry-driven change. In previous posts, we’ve discussed these challenges, as well as the imperatives for the next generation of quality solutions
that will help meet them. Next-generation enterprise quality management systems (QMS) must drive real product quality, link closely with business objectives, enable global harmonization, support enterprise quality, and enable an organization's culture of quality. That’s a tall order for most quality systems that are deployed within Life Sciences organizations today.