'We Survived MDSAP': Cynosure Aces Single-Audit Program Twice; Tells How Your Firm Can, Too
Connie Hoy, executive VP of clinical development and regulatory affairs for the Westford, Mass.-based device-maker, explains how the firm handled audits at two separate facilities under the Medical Device Single Audit Program. Hoy details how her MDSAP experiences unfolded, from the time she was first notified – "I thought, 'I'm either going back to bed or I better turn my fierce on,' so I turned my fierce on" – to the very end of each audit, when the company was handed a few auditor findings that were easily fixed. "There’s not one company that cannot pass the MDSAP audit," Hoy insists. Check out her valuable tips and advice – and colorful anecdotes – in this feature article.
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From 'Back' To 'Front': FDA, Industry Experts Advise Device Manufacturers On Best Inspection 'War Room' Practices – And Don't Forget The Swedish Fish
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.