FDA posted three drug GMP warning letters this week to pharmaceutical firms, one to a compounding pharmacy, one to a GLP site, and two to device manufacturers.
FDA-regulated firms face an enormous challenge keeping up with agency priorities and expectations—especially companies that produce older products within an ever-changing regulatory landscape. While firms continue to manufacture these older products to serve their customers and protect their brand, there are many potential quality compliance issues that can arise.
Join Govzilla’s GMP Quality Expert Jerry Chapman for an informative 1-hour webinar on assessing legacy products for potential GMP compliance gaps and pitfalls.
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 the industry.
GMP expert Jerry Chapman covers the presentation by FDA Office of Combination Products (OCP) Associate Director for Policy John Barlow Weiner in which he reviews PMSR guidance and implementation, the RFD process, and new guidance in progress.
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