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Compliance Corner

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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 Quality

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.

Quality Control Policy & Regulation

Compliance Corner: First Impressions Count During FDA Inspections, Ex-Investigators Say

Referring to a US FDA investigator as an "inspector" might not seem like a big deal, but it is – and doing so can taint an inspection right from the start, industry insider Ricki Chase says. The former director of FDA’s Investigations Branch gives other pointers – including avoiding snatching investigator credentials and asking investigators if they're at the company to inspect the cafeteria. Another former FDA Investigations Branch director, David Chesney, chimes in, offering advice to ensure the best first impression.

Quality Control Policy & Regulation

Compliance Corner: Add These 8 Items To Your FDA Inspection Checklist

Industry insider Steve Niedelman highlights eight points to consider that could ensure quicker, more efficient FDA inspections, including providing "clean" laptops for agency investigators, and making sure that opening presentations are complete and up-to-date.

Quality Control Policy & Regulation

Compliance Corner: 5 Tips For Successful FDA Inspections, From SOPs To Roleplaying

Four industry experts – including a Medtronic quality VP and two former FDA investigators – offer advice on how device manufacturers can better ensure smooth sailing during an FDA audit.

Quality Control Policy & Regulation

Compliance Corner: Medtronic Quality Expert Urges Use Of Problem Statements When Investigating Device Failures – Plus Other Advice

Problem statements written before failure investigations occur can help device-makers organize their thoughts, fix things right the first time and ensure they aren't barking up the wrong tree, a Medtronic quality expert explains in this "Compliance Corner" feature. Also: a Q&A on CAPA effectiveness checks and root cause.

Policy & Regulation Quality

Compliance Corner: 9 US FDA Inspection Questions Answered By Agency Officials, Abbott Quality VP

Are FDA investigators allowed to fish through a messy filing cabinet for documents? And do low-risk class III recalls play into an inspection? FDA investigator Ben Dastoli from the agency's Cincinnati, Ohio, district office, Cincinnati compliance officer Gina Brackett, and Monica Wilkins, divisional VP of QA/RA for device-maker Abbott Laboratories answer those queries and more from manufacturers.

Policy Regulation

Investigator Horror Stories: Industry Insiders Tell Of FDA Inspectional Nightmares – And How Device Firms Handled Them

In this "Compliance Corner" feature, two industry experts give real-world examples of potential FDA inspectional overreaches, including one investigator who followed a device firm's employee into a restroom to stop her from using a cell phone. Yes, that actually happened – and it's just one of many inspectional nightmares that manufacturers have faced when inspected by the agency.

Medical Device Regulation
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