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'Program Alignment' Wants You: Why FDA Is Soliciting Input From Industry For New Facility Inspection Initiative

 
• By Shawn M. Schmitt

The agency is reaching out to manufacturers and other stakeholders for input on communication and training issues related to its upcoming "program alignment" facility inspection scheme, which aims to make inspections more predictable and consistent for investigators and device firms.

FDA is asking the device industry for input on communication and training issues related to its in-the-works "program alignment" inspection initiative.

"We are developing ways to communicate both internally and externally that are really going to strengthen the program," ORA Medical Devices Program Director Jan Welch said June 27 at the Association

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