From 'Back' To 'Front': FDA, Industry Experts Advise Device Manufacturers On Best Inspection 'War Room' Practices – And Don't Forget The Swedish Fish
• By Shawn M. Schmitt
Ever since the first FDA inspection took place decades ago, manufacturers have relied on so-called "inspectional war rooms" – spaces where subject matter experts and others work to fulfill investigator needs – but such back rooms can cause headaches for device firms and stretch out inspections if they select unsuitable workers to staff and manage them. Larry Kopyta, a quality/regulatory VP for Omnyx, says it's vital for employees to be adequately trained on FDA inspection activities, but he notes that it's even more important to not clog up a rear room with an excessive number of workers, warning that things "can easily become out of control. You need to find a good ringmaster." Yet a back room isn't the only place manufacturers should be careful about using the right people. Present in the front room – where investigators traditionally work when onsite at a firm – should be helpful, reliable facilitators that aid investigators with requests and answer an array of questions.
Device manufacturers should identify and position their best and brightest subject matter experts in "war rooms" when FDA comes to inspect, agency and industry experts say. Yet firms must strike the right balance in the number of subject matter experts (SMEs) and other workers in those back rooms to avoid having too many proverbial cooks in the kitchen.
That's because crowding a rear room with an abundance of behind-the-scenes employees could slow down an inspection, they warn. And...
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The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
