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(BSI: Reston, VA ) -- The first step in the risk management process is risk analysis. Risk analysis for medical devices requires the definition of a device's intended use, characteristics related to safety, identification of known and foreseeable hazards, and risk estimation for each hazard. Risk…
(StatPoint Technologies, Warrenton, VA) -- StatPoint Technologies Inc., a leading developer of statistical tools used in data analysis across the spectrum of business management, manufacturing, and scientific research, recently announced the immediate availability of Statgraphics Centurion XVI.…
(FDA: Rockville, MD) -- The U.S. Food and Drug Administration recently announced that it has awarded 83 grants for the 2009 fiscal year totaling $17.5 million to state and local regulatory agencies to boost food and feed safety initiatives among federal, state, and local partners. The grants fund…
(ASQ: Milwaukee) -- The American Society for Quality is offering a three-part prerecorded webinar series that spotlights one health care organizations’ use of the Malcolm Baldrige Performance Excellence Criteria to drive organizational transformation. The webinar series complements the recently…
USDA’s fresh produce chief will join the Food and Drug Administration (FDA) to help develop new food safety rules, as part of a cooperative initiative between the FDA and the U.S. Department of Agriculture (USDA). Today’s announcement comes amid beefed up outreach efforts with key agriculture…
(FDAnews: Falls Church, VA) -- Earn 12 RAC credits while you discover field-tested, ICH Q9 risk management strategies that work for drugs and biologics, in “Applying Quality Risk Management Principles: Moving ICH Q9 from Theory to Practice,” an interactive workshop presented by LearningPlus and…
(PQ Systems: Dayton, OH) -- An option for concurrent-use licensing ushers in a new approach to the use of CHARTrunner from PQ Systems Inc., in its latest release. This “floating license” allows installation on multiple computers, with use limited only by the license itself.
CHARTrunner,…
(IQPC: New York) -- Pfizer, Genentech, AstraZeneca, and Elan are just a few of the companies who will be coming together to share operational excellence best practices and work together to find the optimum way to run their operational excellence programs.
From project valuation for operational…
(Mnitab: State College, PA)-- Minitab Inc. has released Quality Companion 3.2, an update to its software for managing and executing quality improvement projects.
This update introduces new functionality, including a powerful tool for value stream mapping (VSM), a primary technique used in lean…
(Citrix Systems: Fort Lauderdale, FL) -- In a harshly competitive environment with rising consumer expectations, customer satisfaction surveys are an essential tool for listening to customers and developing strategies for improvement. Successful surveys maximize the retention of current clients…
(Sparta Systems: Holmdel, NJ) -- Sparta Systems Inc., the maker of TrackWise software and the market leader in enterprise quality and compliance solutions, announces that Ascent Healthcare Solutions Inc., a Phoenix-based leader in delivering health care resource sustainability, has selected its…
(Camstar Systems Inc.: Charlotte, NC) -- Does it seem like every time you perform a corrective and preventive action, exactly the same problem crops up again? If so, then you need to attend the webinar The Next Generation CAPA System: Recurring CAPAs? Find Root Cause. Enforce Actions. Prevent…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration announces that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.
The IOM study will examine the…
(NIST: Gaithersburg, MD) -- Diamonds, it has long been said, are a girl’s best friend. But a research team including a physicist from the National Institute of Standards and Technology (NIST) has recently found1 that the gems might turn out to be a patient’s best friend as well.
The team’s work…
(Thermo Fisher Scientific: Cambridge, UK) -- Thermo Fisher Scientific Inc., recently announced a new application note to illustrate the capabilities of its Thermo Scientific iCAP 6200 ICP spectrometer for the analysis of toxic trace elements in children’s toys. The dual-view inductively coupled…
(DNV Certification: Houston) -- How do I get started with food safety certification? What’s the process? What are the Global Food Safety Initiative (GFSI) benchmarked standards and which is best for my organization?
Do these questions sound familiar? Do you have more?
Attend "Food Safety…
(Olympus America: Center Valley, PA) -- Industrial engineers, quality control inspectors, and researchers can perform image capture and analysis tasks quicker and easier than ever, thanks to the groundbreaking new Olympus microscopy software platform, Stream v1.3. In industrial laboratory…
(UI: Iowa City, IA) -- A group of researchers at the University of Iowa’s Tippie College of Business is using the principles of more efficient manufacturing processes in an effort to help contain ever-increasing health care costs.
“Whether you’re talking about health care or manufacturing, lean…
(BSI: Reston, VA) -- BSI, a provider of regulatory and quality management reviews and product certification for medical devices, recently launched the CE-Dedicated FastTrack. This new CE marking program is designed to help medical device manufacturers get their products quickly and safely to…
(FDA: Rockville, MD) -- The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness—the Reportable Food Registry (RFR). Food industry officials must use this electronic portal to alert the FDA quickly when they find their products might sicken or kill…
(Delcam: Birmingham, UK) -- CAD/CAM developer, Delcam, has established a dedicated health care division to provide a greater focus on this increasingly important part of its business. The new division will help companies across the medical, dental, and associated industries to apply Delcam’s…
(ASTM: West Conshohocken, PA) -- Four of the biggest names in standards have joined forces to develop an unprecedented resource for medical device standards and related information.
Medical professionals can now access more than 1,300 medical device standards from one single database developed…
(ANSI: New York) -- The American National Standards Institute (ANSI) announced the availability of a new resource for its members that will facilitate enhanced U.S. engagement on standards and conformance in China. The resource was developed jointly with the US-China Business Council (USCBC), the…
(Automation Trainer: Westbrook, ME) -- Automated liquid handling equipment is an increasingly essential component of life science laboratories. Used to boost the productivity and repeatability of volume transfers, automated liquid handlers must be optimized to achieve precision and accuracy in…
Gemba is a Japanese term that has been translated as: place, real place, actual place. Westerners have further defined gemba to include: where the action is, the go-and-see place, where the work is done, the place to go for improvement, and the place where value is added, and more.
The environment…