All News
(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…
(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: 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…
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…
(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,…
(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: 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…
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: 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…
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.…
(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…
(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: 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: 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…
(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…
(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…
(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: 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: 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…
(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…
(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…
(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…
(Drug Information Association: Horsham, Pennsylvania) -- The Drug Information Association (DIA) will host its eighth annual DIA Conference for Contemporary Pharmacovigilance and Risk Management Strategies, January 11–15 in Washington, D.C. This annual event addresses current complexities and…
(FDA: Rockville, Maryland) -- To learn about the development of global initiatives to ensure the integrity of the Pharmaceutical Supply Chain, join regulatory and industry representatives from at the PDA-FDA Pharmaceutical Ingredient Supply Chain Conference, December 3-5, 2008 at Loews…
(HHS: Washington) -- As part of an ongoing strategy to address the food safety issues in China and the United States, and to share ideas to address global food safety, the U.S. Food and Drug Administration (FDA) opened its first office in Beijing, China, on Nov. 19, 2008. The U.S. Department of…
