All News
(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…
Search the internet for “What is SPC?” and there are many definitions and descriptions of statistical process control that are correct but not complete. They are true but not the whole truth.
From the search results, a general definition and description of SPC could be as follows.
Definition: SPC…
(Agilent Technologies Inc.: Santa Clara, CA) -- Agilent Technologies recently introduced Agilent Functional Verification Service (FVS) for users of Agilent gas chromatographs (GC) or liquid chromatographs (LC) that are seeking or maintaining accreditation under ISO/IEC 17025 or similar quality…
ISO 13485 is an international standard that ensures that medical device organizations meet global quality management system regulations. Its aim is to provide consumers with safer medical devices and services.
Based on the eight quality management system regulations of ISO 9001 and its goal of…
(NIST: Gaithersburg, MD) -- The Baldrige National Quality Program (BNQP) at the National Institute of Standards and Technology (NIST) collects suggestions throughout the year on opportunities for improving the Baldrige Criteria for Performance Excellence, the Malcolm Baldrige National…
(USP: Rockville, MD) -- A first-of-its kind collection of standards designed to assist dietary supplements manufacturers in providing quality products to consumers is being released today by the United States Pharmacopeial (USP) Convention. The USP Dietary Supplements Compendium (DSC) will also…
(FDA: Rockville, MD) -- Michael R. Taylor, J.D., a nationally recognized food safety expert and research professor at George Washington University’s School of Public Health and Health Services, will return to the U.S. Food and Drug Administration (FDA) to serve as senior advisor to the…
Failure mode and effects analysis (FMEA) is a systematic analysis technique that facilitates the identification of potential problems (failure modes) within a design or manufacturing process. Problems can then be ranked in order of importance to prioritize improvement actions. These actions are…
(Intertek: Boxborough, MA) -- Intertek, a leading global provider of quality and safety solutions, is working with medical device manufacturers who are currently under pressure to stay compliant under widespread changes to EU regulations.
The European Union has published a revision to its…
(NCQA: Washington) -- Beginning in 2010, the National Committee for Quality Assurance (NCQA) will publicly report on health plans' resource use for patients with diabetes and asthma. The reporting of these two relative resource use (RRU) measures will allow purchasers and consumers to compare…
The Society of Manufacturing Engineers presents a new book from Michael J. Termini, Concept to Customer: Portfolio, Pipeline, and Strategic Project Management (SME, 2009). Termini wrote Concept to Customer in response to the many questions from project managers and novices who have sought his…
(NIST: Gaithersburg, MD) -- Senior leaders from the three organizations selected for the 2008 Malcolm Baldrige National Quality Award, as well as representatives from past award recipients, will share their best practices and results at one-day regional conferences on Sept. 15 in Milwaukee, and…
(EtQ Inc.: Farmingdale, NY) -- EtQ Inc. has announced enhanced features in the latest release of its web-based enterprise system for quality, compliance, and environmental health and safety management, Reliance 6.2.
EtQ Reliance 6.2 incorporates enhanced features and utilities including…
(Dyadem: Toronto, Canada) -- Dyadem recently upgraded its Stature enterprise risk management platform. Stature 4.0 will enable Dyadem’s customers to make more informed and strategic decisions about the production processes and products they manage.
The Stature platform is built on the…
It started slowly but surely. With the slump of the U.S. economy, companies started downsizing first by the dozens, then by the hundreds. Today, thousands of organizations across the country have in one way or another had to perform some kind of cost-cutting measure.
And as unemployment started…
The international quality standard, ISO 22000—"Food safety management systems—Requirements for any organization in the food chain" ensures that no matter how many times food changes hands, the food products, according to their intended use, are safe for the consumer. Published in September 2005,…
(LRQA: Coventry, UK) -- This free, live two-hour webinar will be held on July 1, 2009, and will take place twice—at 09:30 and 17:30, UK time—to account for global time zones. The content is the same for both times.
Following up on from the initial LRQA Food Safety Webinar in April, 2009, this…
(Labtronics: Guelph, ON) -- Labtronics Inc. announces the release of LimsLink 4.1 SP1, a service pack for LimsLink 4.1 users that delivers the latest updates and enhancements for LimsLink, Labtronics’ configurable solution for integrating laboratory instruments.
“At Labtronics we believe in…
