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On October 8, the federal government arrested three people in Southern California on suspicion of selling counterfeit integrated circuits (ICs) used in the manufacture of electronic devices to the U.S. Navy. The government executed search warrants at three business locations, two residences, and a…
(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…
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…
(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…
(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…
(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…
(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…
(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…
(SigmaQuest: Sunnyvale, CA) -- SigmaQuest Inc., the leader of on-demand, scalable solutions for product quality management, and Wilson Sonsini Goodrich & Rosati, a provider of legal services to technology, life sciences, and growth enterprises worldwide, are hosting a free webinar titled, "…
(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration (FDA) recently announced it has stepped up its efforts to prevent noncompliant investigators and others from participating in new product development. The FDA's procedures for debarment and disqualification have been enhanced to…
On Tuesday, Aug. 4, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing on protecting patients from defective medical devices. The principle element of the hearing was to debate the bill S 540: Medical Device Safety Act of 2009 “To amend the Federal Food, Drug, and…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) today announced an agreement to launch a bilateral good clinical practices (GCP) initiative, designed to ensure that clinical trials submitted in drug marketing applications in the…
(The Conference Board: New York) -- The number of U.S. companies with an offshoring strategy has more than doubled from 2005 to 2008 and very few plan to relocate activities back to the United States, according to Duke Offshoring Research Network's fifth annual report on offshoring trends,…
(TÜV SÜD America Inc.: Peabody, MA) -- TÜV SÜD America Inc. announced that it will participate with TÜV SÜD de México as a Gold Sponsor at the SQF International Conference on October 21–23, 2009, at the Fiesta Americana, in Guadalajara, Mexico.
The annual conference brings together food…
(ARTEL: Chicago) -- ARTEL, the global leader in liquid handling quality assurance, announces that its Pipette Tracker software can now be used as an effective laboratory management tool to track and monitor pipette operator performance. When used in combination with the ARTEL Pipette Calibration…
(Veriteq: Vancouver, BC, Canada) -- Veriteq Instruments recently announced the release of their new viewLinc monitoring and alarming system for regulated controlled environments. The viewLinc 3.4 validatable system provides continuous, gap-free records and automates the generation and delivery of…