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Compliance Corner

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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.

Compliance Quality Control Compliance Corner

Compliance Corner: When Should Your Firm Revalidate Under Process Validation? An Expert Explains

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.

Compliance Quality Control

Compliance Corner: 5 Key Steps To Reassessing Management Reviews At Your Firm

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.

Compliance Quality Control

Compliance Corner: FDA Wants You To Take These 5 Actions After A Facility Inspection

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.

Compliance Quality Control

Compliance Corner: 20 Things You Should Never Say To An FDA Investigator

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.

Compliance Compliance Corner

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.

Quality Control Compliance Corner

Compliance Corner: Abbott Quality VP Wants You To Talk About These 5 Things At Management Reviews

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.

Quality Control Compliance

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.

Quality Control Compliance

Compliance Corner: 6 Tips From US FDA To Ensure Robust Software Validation

Device manufacturers can avoid headaches during agency inspections by following this advice from two FDA investigators.

Quality Control Compliance

Compliance Corner: Keep 'ALCOA' In Mind To Ensure Quality Data Integrity, Says US FDA Expert

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.

Quality Control Compliance

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.

Risk Management Compliance

Compliance Corner: 7 Things To Do – And Not Do – When FDA Inspects Your Facility

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.

Quality Control Compliance

Compliance Corner: Have Tech-Savvy People In Place For 'Live' FDA Inspections

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.

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