Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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.
US FDA's Sean Boyd says what happens after an inspection is over is just as important as what happens before and during one. Here he lists five critical post-inspection activities that device-makers should keep in mind.
Medical device manufacturers might be tempted to defend themselves during a US FDA inspection. But longtime industry insider Steve Niedelman says there are 20 instances in which firms should remain tight-lipped.
Investigator Horror Stories 2: More Terrifying Tales Of FDA Inspections Gone Bad – And How They Were Fixed
Eli Lilly global quality leader Francis Blacha and former FDA investigations branch director Ricki Chase talk about shocking inspectional run-ins, from an agency investigator who hollowed out a notebook to hide a voice recorder, to another who donned a disguise to force a face-to-face meeting with a company CEO – and more. Find out how they handled the nightmare audits in this Compliance Corner sequel to last year's most-read Medtech Insight story.
Monica Wilkins, divisional VP of medical, quality and strategic support for device-maker Abbott Laboratories, returns to Compliance Corner with more tips for management reviews. This time, she pinpoints five things that manufacturers should discuss during the meetings.
Compliance Corner: There Are 7 Reasons Why You're Screwing Up Management Reviews, Abbott Quality VP Says
Monica Wilkins, divisional VP of medical, quality and strategic support for device-maker Abbott Laboratories, lays out seven distinct issues that can keep manufacturers from getting the most out of management review meetings.
Device manufacturers can avoid headaches during agency inspections by following this advice from two FDA investigators.
When inspecting a device manufacturing facility, FDA investigators will check a company's quality data to make sure it's Attributable, Legible, Contemporaneous, Original and Accurate – or "ALCOA," the agency's national device expert says.
Compliance Corner: US FDA Wants Device Firms To Fully Consider Risks To Consumers, Agency Expert Says
Manufacturers that don't consider all possible dangers their products can pose to consumers is a growing problem, FDA's national expert on devices says. Phil Pontikos also is worried that firms aren't putting their best foot forward when using risk assessment tools.
Two former US FDA investigators offer do's and don'ts for device firms to follow when their facilities are being inspected. Tips include everything from not boring an investigator during an opening meeting, to making sure quality system fixes are communicated to auditors in a timely fashion.
Device manufacturers should have appropriately skilled individuals fetching and handling electronic information to be handed over to US FDA investigators, says a former Johnson & Johnson quality & compliance expert. "The inspectional front room has to be able to manage live information, which means you have to have people who know the IT tools and how to navigate them, and how to find things quickly and explain them," Teresa Gorecki advises.
All set! This article has been sent to email@example.com.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.