All News
(NIST: Gaithersburg, MD) -- Letitia Baldrige, sister of Malcolm Baldrige, died Mon., October 29, 2012, at the age of 86. In announcing her passing, her son Malcolm Hollensteiner told the Foundation for the Malcolm Baldrige National Quality Award, Inc., that “she loved the board and took such pride…
(FDA: Washington, D.C.) -- In response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration (FDA) proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.
A UDI system has the…
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) just concluded its two-day current good manufacturing practices (CGMP) conference, which was co-sponsored by the U.S. Food and Drug Administration (FDA). Held June 4–5, 2012, in Baltimore, the conference met with…
(ISPE: Tampa, FL) -- The Food and Drug Administration (FDA) has joined with the International Society for Pharmaceutical Engineering (ISPE) to deliver an integrated learning conference focused on industry and regulatory viewpoints concerning current good manufacturing practices (CGMP). The…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.
“When it comes to getting new biosimilar products on the market, the FDA has…
(FDA: Silver Spring, MD) -- The Food and Drug Administration (FDA) and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.
The recommendations would authorize the FDA…
(FDAnews: Falls Church, VA) -- Is failure mode and effects analysis (FMEA) the cornerstone of your risk management program? Consider this quote from the Food and Drug Administration’s (FDA) quality systems regulation expert Kim Trautman: “Are FMEA or FMECA… good tools? Yes. They are very good tools…
(FDAnews: Falls Church, VA) -- It’s your job to know the FDA’s medical device regulations inside out. But device regulations can be a moving target. Here’s a resource that can help keep them in your sights.
In its first revision in three years, the 2011 Guide to Medical Device Regulations is…
(FDANews: Falls Church, VA) -- FDAnews has announced details of its upcoming CAPA is King Virtual Conference: Tools, Tips, and Techniques for Assuring Compliance, to be held online Dec., 13, 2011, 10 a.m.–4 p.m. EST.
These days more than two-thirds of all Food and Drug Administration (FDA)…
A lot has happened since computer-assisted metrology was invented. In its early stages, computer numerical controlled (CNC) machines were used to control manufactured parts, and it was not until the 1970s that computer-controlled coordinate measuring machines (CMMs) appeared on the market and…
(FDAnews: Falls Church, VA) -- FDAnews has announced details of its upcoming 4th Annual Risk Management and Drug Safety Summit: Building an Effective Global Risk Management and Drug Safety Program, scheduled for Nov. 1–2, 2011, in Washington D.C.
All professionals in regulatory affairs, risk…
(STAT A MATRIX: Edison, NJ) -- Can your organization survive a Food and Drug Administration (FDA) inspection? Are you aware of the different aspects of your business that the FDA will be inspecting? This course, “FDA’s Quality System Inspection Technique (QSIT),” is intended to facilitate…
(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:
•…
