The FDA Group's Director of Quality and Service Assurance, Brie Stoianoff, and her husband, Kevin Byrne joined the hosts of Portland Today to discuss their personal struggle with MS and how they're raising money to promote MS research in search of a cure.
Kevin was diagnosed with MS while deployed overseas, serving as an air cavalry commander with the U.S. Army.
Together, and with their 7-year-old daughter, Eleanor, their focus is a constant effort to endure the debilitating effects of this disease, fundraise for efforts to find a cure, and support all those living with MS.Continue Reading
The Medical Device Single Audit Program (MDSAP) is an important new global initiative intended to harmonize regulatory efforts around the world.
But despite looming deadlines, comparatively few medical device companies have a meaningful understanding of the advantages (and disadvantages) of pursuing MDSAP certification and how to prepare accordingly.
We're hosting a free webinar offers a clear and practical guide to understanding what the MDSAP is, the kinds of device manufacturers that stand to benefit from it, what to consider before pursuing certification, and how to prepare for the audit sequence.Continue Reading
The Esophageal Cancer Action Network, a national nonprofit organization based in Baltimore, recently filed a citizen's petition with the U.S. Food and Drug Administration asking the agency to require warnings about the cancer risk of acid reflux on the labels of over-the-counter medications.
While labels on these over-the-counter medications currently warn people to get their doctors' recommendation before taking the medicine and warn against long-term use, they don't mention a cancer risk.Continue Reading
Whether you're embarking on a computer system validation (CSV) or system remediation project, you'll likely need to navigate a quagmire of organizational, team, and human dynamics to come out successful at the other end.Continue Reading
To Quality Assurance professionals in the pharmaceutical industry, Quality Risk Management (QRM) is a process attributed to a specific action: Assessing quality risks to a drug across its lifecycle.
But the value of QRM isn't pinned to a narrow set of product quality risks, nor does it have to be the long and arduous process it's often thought as. As an adaptable review framework, it can be applied in differing degrees to a number of situations where risk management plays a major role in the decision-making process.Continue Reading