How AI Tools Will Transform Quality Management In The Life Sciences

FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.

New Podcast: AI Explainability

In a fascinating podcast, Jon Speer, Founder and VP QA/RA, Greenlight Guru, interviews Marla Phillips, Director, Xavier Health, on AI explainability and why it matters in healthcare. As AI begins to transform how the pharma and medical device industries operate, overcome the media-generated hype and fear of AI to discover its benefits when using it responsibly. 

FDA’s Top Ten Drug GMP Inspection Citations for FY 2016

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.