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'Program Alignment' Snaps Together: What's Next For US FDA's Inspection Scheme

 
• By Shawn M. Schmitt

Almost six months into its new "program alignment" inspection approach, FDA's initiative to inspect along commodity lines is still gaining its sea legs. A key FDA official says the agency is taking steps to train and retain specialized investigators. Meanwhile, FDA wants to use a geographic information system (GIS) tool to keep tabs on where investigators are inspecting.

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Nearly six months after US FDA rolled out the most sweeping changes ever to its approach to facility inspections, the agency's "program alignment" initiative continues to gain its sea legs.

Program alignment is "only five-plus months old, so it's not going to be perfect yet, but we're getting there," said Ellen Morrison, associate commissioner for operations within FDA's Office of Regulatory Affairs, and

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