This past week I was invited to speak at the Contract Pharma Contracting and Outsourcing Conference in New Jersey, where I spoke on how to
Two recent articles – one in the Washington Post and one in the Wall Street Journal – have raised the spectre of how smartphone medical
New European medical device regulations are due within 18 months. The new rules will update the current Medical Device Directives (MDDs) for the 21st century,
Earlier this year, I spoke with medical product liability expert and lawyer, Sara Dyson, on ways to reduce drug and device product liability risks through
“Which is better – hiring a consultant to come and conduct an onsite workshop for my team or sending folks out to various third-party classes
Last week I spoke to the NIH biotechnology business leadership in Bethesda, Maryland. To the standing room only crowd, I laid out the challenges that
Expecting something from the FDA is a risky endeavor, and that makes it all the more worthwhile to read the tea leaves every once in
Last week, I served as the keynote quality speaker at the international Personal Care Products Council’s 2011 Science Symposium in Newark, New Jersey. The turnout
Since FDA announced its intent to vigorously enforce 21 CFR 11, I’ve collected various questions posed by attendees at my workshops and speeches on 21
Supplier quality management is complicated enough. Yet, too often, we shoot ourselves in the foot, making supplier qualification and oversight more complicated, more removed from
FDA Commissioner Hamburg has created a new FDA enforcement directorate, the Office of Global Regulatory Operations and Policy, under Deb Autor. The goal is to
The FDA recently awarded Johns Hopkins University a three-year contract to develop advanced analytical strategies to mine the data residing within multiple FDA databases. The
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