A team of FDA officials and industry professionals working through Xavier Health has taken a major step towards forging the use of artificial intelligence (AI), by providing a Good Machine Learning Practices (GmLP) document for the evaluation and use of continuously learning systems (CLS).
Dr. Marla Phillips, Director, Xavier Health, took part in a panel discussion on Capitol Hill, July 17, 2018. The event was titled “AI Explainability: What that Means and Why It Matters in Healthcare.”
At the Xavier Health web conference in February 2018, Half Day with FDA — The Future: Alignment and Reliance, CDRH Office of Compliance Regulatory Affairs Deputy Director Capt. Sean Boyd presented a proposed reorganization plan that will collapse the Center’s seven offices into four.
At the FDA/Xavier PharmaLink conference in March 2017, FDA National Expert Investigator Robert Tollefsen presented a case study on a pharma company with compliance problems, and led a group discussion with the audience on what the appropriate actions would be for the company to undertake, given the circumstances.
At the 2017 FDA/Xavier University PharmaLink conference Robert Tollefsen, an FDA National Expert Investigator – Drugs/Computers, Pharmaceutical Inspectorate/Level III Certified in Drugs, Medical Products and Tobacco Program Operations Branch, and Dell Moller, FDA Cincinnati District Supervisory Investigator, presented FDA’s top ten drug GMP inspection citations for FY 2016. This article includes a brief comment/analysis on the findings and additional information regarding inspection trends and other inspection findings.
Xavier Health Director, Dr. Marla Phillips, presented at the 121st Association of Food and Drug Officials (AFDO) conference, June 19, 2017, in Houston.
In support of FDA’s intent to allocate its resources based on risk, Xavier University and PwC launched a Metrics Initiative in August 2014 to identify product quality risk metrics linked to patient safety that could be viewed during an inspection.