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.