Compliance Corner: On-Site Facility Inspections Are Back. Is Your Firm Adequately Staffed?
King & Spalding quality expert Eric Henry urges device makers to be inspection-ready by making sure the right people are in the right roles.
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‘War Room’ Death Knell? Edwards Lifesciences Expert Predicts Inspectional Front, Back Rooms Will Be Pandemic Victim
Medtech quality expert Rob Becker says the COVID-19 pandemic has likely changed the structure of audits and inspections forever, possibly ending the use of on-site “front rooms” where inspectors would work and “back rooms” where company employees would fulfill requests for documents and other items.
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.
From Recalls To Clinical Trials, Medtronic’s Developing A ‘Systematic Approach’ To Capturing Patient Input
The medtech behemoth is putting in place a company-wide framework to make sure the voice of the patient is heard across the firm’s premarket and postmarket activities.