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November 2008 |
Volume 12, Number 11 |
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FDA’s Risk-Based Approach To Facility Inspections Undergoing Refinements
FDA IS REVIEWING ITS RISK-BASED INSPECTION APPROACH to make sure it is learning all it can about problematic manufacturers and devices. The agency weighs product and manufacturer risk when deciding which firms to inspect, but "we’re working to improve our model," says Larry Spears, deputy director of regulatory affairs in CDRH’s Office of Compliance. "We want to get input from other parts of the agency, particularly the Office of Regulatory Affairs, to help us make sure that we’re truly identifying all risk." Speaking from the trenches, Baltimore District Office device investigator Lori Lawless tells manufacturers what to expect during an FDA inspection. Because investigators use FDA’s publicly available Quality System Inspection Technique, "there should really be no reason why an FDA-483 form needs to be issued," she says...
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| October 2008 |
Volume 12, Number 10 |
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Extending ‘Lean’ Principles To Quality Systems
ADOPTING "LEAN" MANUFACTURING may be an option for some device firms as they cut costs during rough economic times, but the concept should be extended to their quality systems to prove truly effective, experts say. "Don’t make quality lean, but integrate quality throughout your lean process," says Linda Lovett, a consultant who implemented lean quality methods at Abbott Laboratories and Medtronic subsidiary Kyphon. Meanwhile, another Medtronic division, Physio-Control, is optimistic it will soon clear up its FDA compliance problems in part because it is adopting lean quality, and small manufacturer Osmetech says it now closes CAPAs quicker because of the technique. "By applying that tool, I’m able to have regularly scheduled meetings for CAPAs," says Bob Dicheck, VP of quality & regulatory for Osmetech...
FDA’S HUMAN FACTORS PROGRAM has come a long way over the past few decades, but more needs to be done to keep it relevant, says Pete Carstensen, a former senior systems and human factors engineer at the agency’s device center...
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| September 2008 |
Volume 12, Number 9 |
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Adverse Events Mushroom 144% In 2007; Various Factors At Play, FDA Says
ADVERSE EVENTS REPORTED TO FDA VIA ITS MDR PROGRAM continue to skyrocket, leaving agency officials to hope that a soon-to-be-mandated switch to electronic Medical Device Reporting (eMDR) will ease its workload. According to statistics from CDRH’s Office of Surveillance and Biometrics, MDR reports spiked 144 percent between 2006 and 2007 – and the trend shows no signs of stopping. Currently only 12 manufacturers have joined the eMDR program, which has led FDA to reach out more aggressively to industry. "Each report that comes electronically is one less report we have to do data entry for," says Indira Konduri, chief of OSB’s Information Analysis Branch. Plus, industry experts advise firms on how to set up eMDR programs of their own...
INFORMAL MEETINGS FOR ELECTRONIC MDR participants hosted monthly by AdvaMed...
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| August 2008 |
Volume 12, Number 8 |
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To Ensure Workable Procedures, Consult Your Workers, FDA Advises
EFFECTIVE QUALITY SYSTEM PROCEDURES begin with listening to employee feedback, FDA quality systems expert Kim Trautman tells device manufacturers. She points out that some firms have too many procedures, while others stuff their SOPs full of extraneous information, which is why it’s important for companies to ask workers to sound the alarm when they become overwhelmed. Managers "need to go to the people who are doing the processes and determine what procedures they’re utilizing, how they’re utilizing them, and whether [the SOPs] are confusing or bouncing them around to too many different places," Trautman says. Also, officials at Welch Allyn, Thoratec and Philips Consumer Healthcare Solutions discuss their approaches to building strong SOPs...
REFORMS AT BOSTON SCIENTIFIC have allowed the company to manufacture products based on a "new foundation of quality and a new way of doing things," the firm’s recently appointed quality chief, Fred Colen, says in an interview...
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