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NSF International's Brian Ludovico offers up advice for device-makers facing an audit under the Medical Device Single Audit Program.
Investigator Horror Stories 3: Boozing On The Job? Yup, That Happened – As Have These Other Shocking Tales Of Irregular FDA Inspections
In the final chapter of our Investigator Horror Stories trilogy, former US FDA investigations branch director Ricki Chase tells how one agency investigator blatantly drank alcohol and asked for bathing suit suggestions during an audit in Greece, and longtime industry insiders Steve Niedelman and David Chesney offer up three bone-chilling stories of investigators who stepped over the line. Check out how they handled the outlandish inspections in this Compliance Corner threequel.
FDAer-turned-consultant Heather Rosecrans offers valuable tips for a successful submission, from avoiding sending a PMA or 510(k) to the agency during the annual holiday season, to requesting a copy of an FDA reviewer's work through a Freedom of Information Act request – and more.
Medtech Tips: 'Don't Be A Data Dump' When Submitting New Products For US FDA Review, Pre-Market Expert Says
Heather Rosecrans, former head of the FDA device center's 510(k) review staff, says manufacturers should be careful not to bombard the agency with a mountain of unnecessary information in new product submissions. She also offers advice on what firms should do if they run into problems with a reviewer.
Compliance Corner: Listen To 'DRUM' Beat When Writing An After-Inspection Response To FDA, Expert Says
Longtime device industry insider Steve Niedelman shares some best practices for drafting an effective response letter to US FDA following an unfavorable facility inspection.
Sean Boyd – deputy director for regulatory affairs for the Office of Compliance within US FDA's device center – wants device-makers to take a few steps to ensure that problems identified by investigators during an inspection are adequately addressed.
Bill Maisel – director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health (among other titles) – says there are four things device-makers should do to make sure they succeed during the product-review process.
Compliance Corner: Contract Sterilization Can Be The Bane Of Device-Makers. FDA's Device Expert Sees These 6 Issues
US FDA's Phil Pontikos highlights six problem areas related to contract sterilization that agency investigators routinely see when inspecting manufacturing facilities, from aging facilities to troublesome personnel, and more.
From cautioning against relying too heavily on a vendor's Certificates of Analysis, to advocating for more robust supplier audits, two US FDA investigators and the agency's national device expert offer device-makers advice for keeping vendors in line.
Compliance Corner: FDA Investigator Lists 7 Common Human Factors Problems, Says Usability Is 'Overlooked'
Longtime agency investigator Laureen Geniusz reveals seven usability issues that agency investigators regularly see when inspecting medical device manufacturing facilities – troubles that could jeopardize patient safety. Her chief concern? "Human factors seems to be overlooked and not fully understood," Geniusz says.
Compliance Corner: Suppliers Can Wreak Havoc On Process Validation Outcomes. Here Are 4 Ways To Keep Them In Check
Having a stellar supplier qualification program in place can lessen the variability in a device-maker's validated processes, says industry expert (and former FDAer) Ricki Chase. She notes that using tools such as questionnaires and onsite audits to determine the suitability of vendors, as well as requalifying and monitoring suppliers of components and services, is essential. "Suppliers can affect your validation activities. Suppliers can completely destroy everything you've put a lot of hard work into," Chase says.
Conducting process validation activities isn't a one-and-done deal for device-makers; rather, they must revalidate manufacturing processes from time to time, and when necessary. QA/RA expert Mark Durivage highlights an array of situations that could trigger the need for revalidations.
Abbott Laboratories' quality VP, Monica Wilkins, outlines five steps that device-makers should take when reevaluating their management review process to make sure they get the most out of the meetings.
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