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(IQPC: New York) -- The International Quality and Productivity Center (IQPC) will hold its 10th Lean Six Sigma for Biotech, Pharma, and Medical Device Excellence event in San Diego, July 26–28, at the Hilton San Diego Resort.
Explore how to leverage lean Six Sigma and operational excellence by…
(A2LA: Frederick, MD) -- The American Association for Laboratory Accreditation (A2LA) recently announced that its first U.S. medical testing laboratory has earned accreditation in accordance with the stringent international requirements of ISO 15189—“Medical laboratories—Particular requirements…
(Sparta Systems Inc.: Holmdel, N.J.) -- Sparta Systems Inc., the maker of TrackWise software and the market leader in enterprise quality and compliance management solutions, has announced the general availability of version 8 of its TrackWise enterprise quality management solution (EQMS). Already…
(High Technology Seminars: Cold Spring, NY) -- High Technology Seminars will present a seminar in human error prevention Oct. 26–27 in San Antonio. Anyone whose objective is to improve productivity, safety, and quality will benefit from this two-day event. The principles and practices of human…
(Plex Systems: Auburn Hills, MI) -- Plex Systems Inc., provider of the No. 1-rated enterprise resource planning (ERP) software for manufacturers, announces live demonstrations of Plex Online’s comprehensive ERP solution for motor vehicle suppliers and manufacturers on Tuesday, June 8, from 2 p.m.…
(Sparta Systems: Holmdel, NJ) -- Current and anticipated regulatory changes are the chief driver of life science organizations’ quality management initiatives, according to a recent poll by Sparta Systems Inc., the maker of TrackWise software. Of the quality professionals surveyed, 97 percent…
(Beta LaserMike: Dayton, OH) -- Beta LaserMike, a global provider of precision measurement and control solutions, will display its comprehensive portfolio of system solutions for accurately and cost-efficiently measuring medical tubing during production at Medical Design & Manufacturing East…
(Eriez Manufacturing Co.: Erie, PA) -- Eriez’ E-Z Tec X-ray Inspection Systems deliver the highest level of product and packaging integrity for pharmaceutical applications.
“When it comes to foreign object detection, most companies leave themselves vulnerable as they restrict inspection of…
During the last few years, food contamination recalls have brought the concept of global food safety to the forefront, leading to the establishment of new global food safety standards. Now more than ever, it is critical that any organization producing, handling, or distributing food products has a…
(PLMplus Inc.: Framingham, MA) -- PLMplus Inc. has announced the beta release of PLMplus for medical device manufacturers, an on-demand, subscription-based solution that combines quality management system (QMS) and product life-cycle management (PLM) features into a single, integrated, ready-to-…
(GxPi Ltd.: Nottingham, UK)– Regulatory compliance experts GxPi announce the availability of its leading electronic document management system (eDMS) “x-docs” as a hosted software service. x-docs hosted enables small and medium-sized organizations in the biotechnology, pharmaceutical, and health…
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global nonprofit association of 24,000 pharmaceutical science and manufacturing professionals, and the U.S. Food and Drug Administration (FDA) are co-sponsoring FDA-ISPE Collaboration: Pharmaceutical Quality…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) is asking commercial food transporters to follow new guidance the agency issued to reduce the chances of physical, chemical, biological, and other risks during transportation of foods while the agency reviews current…
(Sparta Systems: Holmdel, NJ) -- Sparta Systems Inc., the maker of TrackWise software and the market leader in enterprise quality and compliance management solutions, announced the release of its TrackWise Audit Execution Package. The new offering builds upon the existing robust audit capabilities…
(InterTech: Skokie, IL) -- Quality engineers seeking cost-effective ways to collect and archive test data for product life-cycle management systems and quality assurance, can now use the InterTech Development Component Tracker System, which integrates bar codes, scans, and software tracking of…
(HSM Americas Inc.: New York) -- The world’s greatest thought leaders in the field convene at the World Innovation Forum, June 8–9, at the Nokia Theatre in New York City, to provide actionable insights into the central issues at the heart of innovation today—marketing, Web 2.0, health care, social…
(Camstar: Charlotte, NC) -- Medical device companies are operating in a challenging environment of continuously innovating and launching new products while reducing product and process variability and risk and simultaneously complying with stringent Food and Drug Administration (FDA) regulations.…
(IQMS: Paso Robles, CA) -- IQMS, an innovator in the design and development of extended enterprise resource planning (ERP) software, recently announced the release of its Quality Audit Module, the most recent addition to the IQMS EnterpriseIQ suite of products. Using the new Quality Audit Module,…
(FDANews: Falls Church, VA) -- FDAnews has announced details for its 7th Annual Medical Device Quality Congress to be held June 2–4 in Bethesda, Maryland.
Changes affecting medical device firms in 2010
The year 2010 has begun with a bang. A new director at the Center for Devices and…
(PerkinElmer Inc.: Waltham, MA) -- PerkinElmer Inc., a global provider focused on the health and safety of people and the environment, recently announced that the company’s inductively coupled plasma-mass spectrometer (ICP-MS) technology can help ensure that traditional Chinese herbal medicines…
(Cognex Corp.:Natick, MA) -- Cognex Corp. recently announced In-Sight Track & Trace, an add-on software package for Cognex In-Sight vision systems. In-Sight Track & Trace delivers a ready-to-deploy data capture and verification solution designed to help pharmaceutical and medical device…
More than 90 percent of all food manufacturers have less than 200 employees. Yet, these small food manufacturers are held to the identical regulatory quality and safety standards as organizations with tens of thousands of employees. Surprisingly it is still not uncommon to find a small baked goods…
(FDA: Washington) -- As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration (FDA) is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.
Posted in…
(DNV: Houston) -- A study being conducted by Michigan State University (MSU) on behalf of DNV finds that U.S. consumers are highly aware of food safety issues and they have high recognition of third-party certification as an effective signal of food safety assurance. The consumers strongly prefer…
(Sparta Systems: Holmdel, NJ) -- Sparta Systems Inc., the maker of TrackWise software and a provider of enterprise quality and compliance management solutions, has announced that a significant percentage of medical device companies currently submitting “high-volume” reports, leverage its TrackWise…
