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QualiPedia: ISO 22000
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,…
Event: LRQA Food Safety Webinar Series, Part 2
(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…
Product News: Service Pack Release for LimsLink 4.1
(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…
Product News: Sparta Systems--TrackWise Clinical Quality Management Solution
(Sparta Systems: Holmdel, NJ) -- Sparta Systems Inc. recently announced the availability of TrackWise Clinical Quality Management Solution, providing an end-to-end system that streamlines the oversight of business-critical clinical trial processes and helps ensure compliance with global regulatory…
Event: "Infusion 2009"-- Quality's Role in Driving Down Costs
(InfinityQS: Chantilly, VA) -- Learn how to maximize your investment in InfinityQS by attending its third annual user conference. Infusion 2009 features a new three-track format to empower you with the tools and skills you need to help your business save time and money. Hear from InfinityQS…
Sparta Systems Outlines Tips and Tactics to Prepare for eMDR Mandate
(Sparta Systems: Holmdel, NJ) -- Sparta Systems Inc., the maker of TrackWise software and the market leader in enterprise quality and compliance management solutions, has outlined its recommendations to help companies prepare for electronic Medical Device Reporting (eMDR), the expected regulation…
Going Low Profile in Afghanistan
This is the second report from the author, who is currently working in Afghanistan. Don’t miss his first article, “Ensuring Quality in a War Zone.”  --Editor They told us the road was clear. They didn’t say it was safe; it was a dirt road that ran seven kilometers through the district of Shah…
Product Announcement: EtQ Adds Graphical Decision Tree to Reliance 6.2
(EtQ: Farmingdale, New York) -- The EtQ decision tree allows users to create a web-based list of related questions that are dependant on each other, so that the results of the questions will impact the business process and produce quantitative results such as a risk ranking, subsequent questions,…
Survey Shows Effect of Economy on Manufacturers
(MFGWatch: Atlanta) -- Results of a survey recently conducted by MFGWatch give a snapshot on the state of sourcing, sourcing preferences, company growth projections, and reactions to economic conditions. More than 200 purchasing professionals and engineers from the manufacturing industry…
FDA Forms Transparency Task Force
(FDA: Silver Spring, Maryland) -- The U.S. Food and Drug Administration (FDA) recently announced the formation of a task force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making process. To support the efforts of the task force, the FDA…
QualiPedia: REACH--EU Hazardous Chemical Standard Reaches US
The European Union is working to make products safer for consumers and manufacturers alike. Its new regulations concerning chemicals used in product makeup, REACH, will extend across the pond to affect chemical standards in the United States. The new legislation will make everything from the…
FDA Awards $1 Million in Grants for Food and Feed Safety
(FDA: Silver Spring, Maryland) -- The U.S. Food and Drug Administration (FDA) recently enhanced its food and feed protection initiatives with the award of three one-year Food Safety and Security Monitoring grants totaling $1 million to the states of Arkansas, Nebraska, and Wisconsin. The funds…
Seventy Apply for 2009 Baldrige Award
Baldrige award medallion. (NIST: Gaithersburg, MD) -- Seventy organizations have taken the first step toward the 2009 Malcolm Baldrige National Quality Award, the nation’s highest recognition for innovation and performance excellence.…
Product Announcement: InfinityQS Announces Major Upgrade to ProFicient 4
(InfinityQS: Chantilly, Virginia) -- ProFicient 4 includes new enhancements and features to further help you improve quality and drive down costs. ProFicient 4 focuses on compliance reporting (useful for companies in regulated industries or companies who need to meet customer specifications), an…
Product Announcement: IBS Drives Quality Management Improvements with CompliantPro 7.2
(IBS: Lexington, Massachusetts) -- IBS, the global leader in enterprise quality and compliance solutions, today announced the latest release of CompliantPro, its web-based quality management software. CompliantPro 7.2 features increased platform support in product infrastructure as well as…
FDA Requires Additional Labeling
(FDA: Silver Spring, Maryland) -- The Food and Drug Administration (FDA) recently issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and…
FDA Stresses Science-Based Compliance and Open Communication
(FDA: Salt Lake City)—Utah-based life science companies are being implored to utilize a scientific approach to regulatory compliance, and to keep the lines of communication open with the Food and Drug Administration. FDA district director Tom Warwick recently spoke with hundreds of life-science…
Updated FDA Process Validation Software
(Aegis Corp.: Lafayette, Colorado) -- Recent deployment of manufacturing process intelligence software “Discoverant,” from Aegis Analytical Corp., enables life science manufacturers to apply the updated principles and approaches for process validation outlined in the United States Food and Drug…
Regulating Nanotechnology
(Project on Emerging Technologies and Food and Drug Law Institute: Washington) -- In 2007, the global market for goods incorporating nanotechnology totaled $147 billion. Lux Research projects that figure will grow to $3.1 trillion by 2015. Is the Food and Drug Administration (FDA) equipped to…
FDA Drug Law and Regulation Conference
(Food and Drug Law Institute: Washington) -- To help organizations stay in compliance with Food and Drug Administration (FDA) regulations, the Food and Drug Law Institute is hosting the “Introduction to Drug Law and Regulation: A Program on Understanding How the Government Regulates the Drug…
FDA Issues Guidances for Industry to Improve the Safety of Food, Feed, Drugs
(FDA: Rockville, Maryland) – In light of recent peanut butter and peanut products recalls, and to help ensure the safety of regulated products in the supply chain, the Food and Drug Administration (FDA) issued three guidances that include the following: Final guidance for industry on "…
ISPE 2009 Tampa Conference
(ISPE: Tampa, Florida) – The International Society for Pharmaceutical Engineering, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, will hold the 2009 Tampa Conference at the Grand Hyatt Tampa Bay in Tampa, Florida, March 2–5. Among the many…
Pilot Program to Improve Drug Safety
(FDA: Rockville, Maryland) -- In an effort to combat counterfeiting and contamination, the Food and Drug Administration (FDA) is launching a voluntary pilot program for drug makers to determine the practicality of developing a secure supply chain program. The goal of the program is to allow the…
FDA Added to High Risk List
(GAO: Washington) – The Food and Drug Administration (FDA) was added to the U.S. Government Accountability Office (GAO) biennial update list of federal programs, policies, and operations that are at “high risk” for waste, fraud, abuse, and mismanagement, or in need of broad-based transformation…
Significant Progress in Food Supply Protection
(FDA: Rockville, Maryland) -- To protect domestic and imported food from contamination, the U.S. Food and Drug Administration (FDA) launched its Food Protection Plan in 2007. Now, the FDA has issued “The One-Year Summary of Progress under the Food Protection Plan,” which describes FDA’s…

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