Author: Jerry Chapman

Part 2: Department of Justice Consumer Protection Branch Doubles in Size to Battle Fraud and Deception in the Drug and Dietary Supplement Industries

This report provides an in-depth look at recent activities by the Consumer Protection Branch of the Department of Justice in the drug enforcement space. While FDA has its own enforcement tools, CPB gets involved if those tools fail to bring bad actors into compliance, which happened several times in 2019.

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Part 1: Department of Justice Consumer Protection Branch Doubles in Size to Battle Fraud and Deception in the Drug and Dietary Supplement Industries

This report provides an in-depth look at recent activities by the Consumer Protection Branch of the Department of Justice in the drug enforcement space. While FDA has its own enforcement tools, CPB gets involved if those tools fail to bring bad actors into compliance, which happened several times in 2019.

Read More »

GMP Compliance for Legacy Products: How to Find and Avoid Potential Quality Issues

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.

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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.

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