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ISO Gives Food Manufacturers New Tool to Control Hazards
(ISO: Geneva) -- Thousands of food manufacturers worldwide stand to benefit from a newly published document in the ISO 22000 series designed to prevent and control food safety hazards. ISO technical specification, ISO/TS 22002-1—“Prerequisite programs on food safety—Part 1: food manufacturing…
FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
(FDA:Washington) -- The U.S. Food and Drug Administration (FDA) has issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies. The Bayesian statistical method applies an…
President’s 2011 Budget Includes Vital Science and Technology Investments
(NIST: Washington) -- President Barack Obama’s fiscal year (FY) 2011 budget submitted today to Congress for the U.S. Commerce Department’s National Institute of Standards and Technology (NIST) proposes a funding level of $918.9 million, a 7.3-percent increase over the FY 2010 appropriations for…
What Will Health Care Reform Mean to the Health Care Quality Professional?
Now that the U.S. Senate and House of Representatives have passed their own versions of sweeping health care reform legislation, the health care industry has its eyes and ears on lawmakers as they negotiate the details of a final, compromise measure.  At this time, it’s hard to predict what…
BSI Unveils “Passport to Europe” Program
(BSI: Reston, VA) -- BSI, a notified body providing regulatory and quality management reviews for medical devices, kicks off its “Passport to Europe” program. As part of the program, BSI will be conducting a series of complimentary educational webinars for emerging, new, and small medical device…
Top-Rated Hospitals Don’t Always Have Superior Outcomes
(American College of Surgeons: Chicago) -- New research published in the January issue of the Journal of the American College of Surgeons finds that while popular hospital rating systems can help identify high-quality hospitals for cardiovascular operations, patients can achieve similar outcomes…
Event: Next Generation Complaint Management for Medical Device Industry
(Camstar Systems Inc.: Charlotte, NC) -- Increasing numbers of customer complaints is typically an indicator of unresolved internal quality failures. Many companies still use fragmented applications, including paper-based systems, which lead to inconsistent processes for receiving and handling…
Product News: Thermo Fisher Scientific UV-Visible Spectrophotometer Web Tool
(Thermo Fisher Scientific Inc.: Madison, WI) -- Thermo Fisher Scientific Inc., recently unveiled an enhanced and easy-to-navigate version of its interactive UV-Visible (UV-Vis) spectrophotometer web tool. The online platform, available at www.thermo.com/selectuv, has been upgraded to include the…
Study: Physicians’ Moods Affect Quality of Care
(BGU: Beer-Sheva, Israel) -- A new study by a researcher at Ben-Gurion University of the Negev (BGU) reveals that physicians’ moods affect the number of prescriptions, referrals, and lab tests ordered, as well as the amount of time they spend talking with their patients. The findings of the…
Harvard Pilgrim to Develop FDA Pilot for Safety Monitoring System
(FDA: Washington) -- The U.S. Food and Drug Administration (FDA) has awarded a contract to Harvard Pilgrim Health Care Inc. to develop a pilot of the FDA’s Sentinel System, which will use automated health care data to evaluate medical product safety. Reports filed by hospitals, health care…
Product News: IQS Announces New Problem Solving Capabilities
(IQS: North Olmsted, OH) -- IQS announces the availability of IQS Problem Solver module that enables organizations to standardize problem solving processes with easy-to-use questioned-based reasoning software. Failure to standardize problem solving, capture reasoning, and effectively use your…
Event: How Managers Maximize Job Productivity and Employee Satisfaction
(Progressive Business Audio Conferences: Malvern, PA)-- How do today’s top managers maximize job productivity and employee satisfaction? Learn how by attending the audio conference: “Becoming the Manager Everyone Wants to Work For,” on Wednesday, Jan. 20, from 1 p.m.– 2 p.m. EST. There are…
Product News: Thermo Fisher Scientific to Unveil Major New LIMS
(Thermo Fisher Scientific: Philadelphia) -- Thermo Fisher Scientific Inc. , the world leader in serving science, will unveil a new laboratory information management system (LIMS) solution at booth No. 2757 at PITTCON 2010 , being held from Feb. 28 through March 5 at the Orange County Convention…
Hexagon Acquires Vision Manufacturer Mycrona GmbH
(Hexagon Metrology: London) -- Following on its recent acquisition of Mahr Multisensor and further expanding its already large footprint in the international metrology market, Hexagon has recently acquired all outstanding assets and intellectual property of Mycrona GmbH, a manufacturer of state-of…
Promoting Quality Improvement Through Health Information Technology
(NCQA: Washington) -- The National Committee for Quality Assurance (NCQA), in collaboration with Pfizer, the world’s largest biopharmaceutical company, has released a new publication providing practical examples of how health information technology (HIT) can be used to improve health care quality…
TÜV SÜD Canada Inc. Acquires Global Advantage International
(TÜV SÜD Canada: Toronto, Canada) -- TÜV SÜD Canada, part of the global TÜV SÜD testing and certification organization, announces the acquisition of a product safety business in Toronto, Ontario, Canada. Global Advantage International is a complete product safety and regulatory compliance…
Event: Quality New Mexico’s Conference and Quality Awards Ceremony
(Quality New Mexico: Albuquerque, NM) — Join Quality New Mexico at the Embassy Suites Albuquerque Hotel & Spa, April 21–22 for a mind opening exploration of new growth and performance strategies. Learn best practices from organizations who have achieved the nation’s highest presidential honor…
Book: Quality Management—Theory and Application
(CRC Press: New York) -- In Quality Management: Theory and Application (CRC Press, 2009), author Peter D. Mauch, Ph. D., demonstrates the necessity of quality as a sustained management activity. Divided into five sections, the book covers staffing, motivation, control, planning, and…
Product News: ProFicient 4 Improves Quality, Compliance, Production
(InfinityQS: Chantilly, VA) -- InfinityQS International, the leading provider of statistical process control (SPC) software, recently announced that Shearer’s Foods, the home of Shearer’s award-winning snacks, has implemented ProFicient 4 to monitor and control manufacturing processes. Shearer’s…
Cutting Through the “Green” Gift Hype This Christmas
(Intertek: Houston) -- You’re shopping for a holiday gift, and you check the packaging to see if it’s eco friendly. How can you tell if the product really is green when it’s labeled “100% recycled,” “biodegradable,” or “environmentally friendly”? The truth is, it can be hard to tell. As demand…
Product News: GAGEtrak Validation Guide
(Cybermetrics: Phoenix) -- The Food and Drug Administration (FDA) defines validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes.”…
Product News: Free Santa’s Customer Survey by Craig Cochran
(Paton Professional: Chico, CA) -- When it comes to customer satisfaction, the Easter Bunny and the Tooth Fairy have been quietly kicking Santa Claus’ rear end. Surprised but determined to make changes, Santa and his elite Elf Council have rallied together to get ahead of the curve and reclaim his…
Product News: TrackWise E-Reporting Helps Companies Meet FDA/EU Mandates
(Sparta Systems: Holmdel, NJ) --  Sparta Systems Inc., the maker of TrackWise software and a provider of enterprise quality and compliance management solutions, is pleased to announce new additions to the TrackWise Electronic Regulatory Reporting (e-reporting) solution to support reporting in the …
Event: “Are You Ready for the Changes to the Medical Device Directive?”
(TÜVRheinland: Newtown, CT) —  Starting March 21, all medical device manufacturers must comply with the Directive 2007/47/EC or risk being pulled from the European Union market. Medical device manufacturers can learn more about the medical device directive at a half-day seminar hosted by…
CLSI Publishes New Proposed Guidelines
(CLSI: Wayne, PA) -- Clinical and Laboratory Standards Institute (CLSI) recently published new proposed-level guidelines. “How to Construct and Interpret an Error Grid for Diagnostic Assays”—Proposed Guideline (EP27-P) describes what an error grid is, why it is useful, and how to go about…

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