Compliance Corner: Device Maker Irrimax Shares 11 Tips For Acing Your Next Virtual Audit
If anyone understands the ins and outs of remote audits, it’s Christy Coleman. She’s VP of regulatory for Irrimax Corp., which has been through four virtual audits under the Medical Device Single Audit Program since the COVID-19 pandemic began. Coleman shares 11 best practices in this Compliance Corner feature.
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From our archives: Despite the COVID-19 pandemic severely curtailing the US FDA’s ability to conduct on-site facility inspections, it’s still vitally important for manufacturers to remain audit-ready. In this collection of a 10-part Compliance Corner series, four longtime industry experts share evergreen advice on the best and worst things firms could do during an inspection.
King & Spalding’s Eric Henry urges manufacturers – particularly ones with facilities outside the US – to be prepared for a virtual audit under the Medical Device Single Audit Program. He explains how.
A former US FDA investigations branch director explains how a paper-based “desk audit” would be performed by the agency in lieu of an on-site quality systems inspection. Last month the FDA hit the pause button on in-person inspections as the coronavirus pandemic rolls on.