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(IRCA: London) -- The International Register of Certificated Auditors (IRCA) has launched a new Pharmaceutical Quality Management Systems (PQMS) Auditor certification scheme (ICH Q10), to support the assurance of global supply-chain integrity.
In a sector that has seen an increase in the…
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global, nonprofit association serving more than 22,000 pharmaceutical science and manufacturing professionals, will present a conference focused on good automated manufacturing practices (GAMP). The event, “…
The Food Safety Modernization Act (FSMA), signed into law by President Obama in January 2011, has been called “historic” because it puts the focus of the Food and Drug Administration (FDA) on prevention—working to ensure that unsafe foods are not distributed in the first place.
FDA commissioner…
(Compliance2go: Houston) -- More organizations are striving to “go green” and develop sustainable strategies, many of which involve using computer- and cloud-based technologies. When it comes to electronic signatures and electronic records, the Code of Federal Regulations Title 21 of the Food and…
(FDA: Silver Spring, MD) -- The FDA has announced that it will open a public docket to begin receiving public comments on the Institute of Medicine’s (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices.
The FDA commissioned the report in…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.
The 510(k) process is the most common review path to market for lower-risk…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) and federal partners has released the Food Related Emergency Exercise Boxed (FREE-B) set, a web-based collection of scenarios that will help government regulators, public health organizations, and the food industry test…
(FDAnews: Falls Church, VA) -- Despite the FDA’s ongoing work with international regulators to improve supplier quality issues, a top FDA official has stated that another public health crisis like Heparin, which occurred in 2010 when Baxter Healthcare distributed misbranded and contaminated doses…
(FDA: Washington) -- The U.S. Food and Drug Administration (FDA) unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the “Pathway to Global Product Safety and Quality.”
“Global production…
(FDAnews: Falls Church, VA) -- Register today for the Eighth Annual Medical Device Quality Congress, scheduled for June 8–9, 2011, in Bethesda, Maryland. This year the conference will feature more than 15 in-depth sessions headed up by leading quality experts, including sessions led by 10 officials…
(FDA: Washington) -- The U.S. Food and Drug Administration (FDA) has announced two new regulations that will help ensure the safety and security of foods in the United States. The rules are the first to be issued by the FDA under the new authorities granted the agency by the FDA Food Safety…
(Mettler-Toledo Inc.: Columbus, OH) -- Mettler-Toledo introduces the BBA226 stainless steel bench scale—a perfect fit for many applications in any industrial environment, with light hose-down requirements.
The BBA226 is a robust, rugged, cost-effective, and multifunctional stainless steel scale…
(EtQ: Farmingdale, NY) -- EtQ LLC has announced the addition of new features and modules in the latest release of its quality management, FDA compliance, and environmental health and safety software, Reliance 8.0. Below is just a sampling of what EtQ’s newest version has to offer:
•…
(Thermo Fisher: Waltham, MA) -- Thermo Fisher Scientific Inc., a global leader in serving science, has announced an upcoming food-safety seminar series that takes place in six locations across Europe. The series, conducted in English, will run from May 3–12, 2011, and each seminar will focus on…
(Mettler-Toledo Inc.: Columbus, OH) -- Mettler-Toledo has introduced the SWC515 Pinmount 316 weigh module for use in the pharmaceutical and food-and-beverage industries. This compact weigh module, which features special-grade stainless steel with capacities of 7.5 t, 15 t and 22.5 t, makes it…
(Pilgrim Software Inc: Tampa, FL) -- Thermo Fisher Scientific Inc., a global leader in serving science, announces that Tampa, Florida-based Pilgrim Software has joined the company’s Informatics Global Partner Alliance. Pilgrim Software will provide integrated risk, compliance, and quality…
(Pilgrim Software Inc: Tampa, FL) -- Thermo Fisher Scientific Inc., a global leader in serving science, announces that Tampa, Florida-based Pilgrim Software has joined the company’s Informatics Global Partner Alliance. Pilgrim Software will provide integrated risk, compliance, and quality…
(FDANews: Falls Church, VA) -- The federal government has just updated and compiled the new nine-volume Title 21 Code of Federal Regulations (CFR) set for 2011 with all the Food and Drug Administration (FDA) rules for drugs, devices, and biologics updated through April 1, 2011.
The new nine…
(FDANews: Falls Church, VA) -- The federal government has just updated and compiled the new nine-volume Title 21 Code of Federal Regulations (CFR) set for 2011 with all the Food and Drug Administration (FDA) rules for drugs, devices, and biologics updated through April 1, 2011.
The new nine…
(ISSISSIPPI: Columbus, OH) -- The International Six Sigma Institute and Secret Society for Imperious Professionals of Process Improvement (ISSISSIPPI) today announced that it will no longer charge customers for access to its industry-leading lean Six Sigma training courses. In response to market…
(ISSISSIPPI: Columbus, OH) -- The International Six Sigma Institute and Secret Society for Imperious Professionals of Process Improvement (ISSISSIPPI) today announced that it will no longer charge customers for access to its industry-leading lean Six Sigma training courses. In response to market…
(United Fresh Produce Association: Washington) -- The top minds in specialty crop research will be on hand this spring at United Fresh 2011, May 2–5, in New Orleans. The annual convention and exposition of the United Fresh Produce Association will again feature posters on food safety, quality…
(United Fresh Produce Association: Washington) -- The top minds in specialty crop research will be on hand this spring at United Fresh 2011, May 2–5, in New Orleans. The annual convention and exposition of the United Fresh Produce Association will again feature posters on food safety, quality…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing…