How Key Pharma and Device Executives Are Developing the Next Generation of Quality Professionals and Leaders

A team comprising over a dozen chief quality officers (CQOs) representing the medical device, pharmaceutical, animal health, and consumer healthcare industries has pooled its collective passion and wisdom—with input from FDA and other drug and device regulatory agencies—to establish and implement an innovative education curriculum that will help develop the next generation of scientists entering […]

Office of Combination Products Official Details Rulemaking and Guidance Agenda

At the Xavier Health Combination Products Summit in mid-September at Xavier University in Cincinnati, Ohio, FDA Office of Combination Products (OCP) Associate Director for Policy John Barlow “Barr” Weiner presented an overview of OCP’s current rulemaking and guidance priorities and discussed the status and agency rationale for each initiative, beginning with the long-awaited OCP guidance […]

FDA Expanding its Sterile Drug NIPP Inspection Pilot to Include Other Dosage Forms

FDA is expanding its New Inspection Protocol Project (NIPP) inspection methodology, initially piloted exclusively for sterile drug manufacturing facilities, to include other dosage forms, beginning this month. The agency also plans to use the information it continues to gather from NIPP to inform the model it uses to choose which drug manufacturing sites to inspect […]

Part 2: How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

At the secondXavier Health AI Summit,Amgen Quality Data Sciences Executive Director Dan Weese and Director Mark DiMartino presented the strategy, approaches, and lessons learned from their implementation of AI tools in Amgen’s quality processes, with a specific focus on the natural language processing (NLP) project used to analyze and trend manufacturing non-conformance reports (NCs). In […]

Part 1: How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence. The AI tool will replace a manual, labor-intensive process with one that can look across large data sets and find correlations between obscure signals […]
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