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(AssurX: Morgan Hill, CA) -- AssurX, Inc., a leading enterprise quality management, risk, and regulatory compliance solution provider, has released the latest update to its AssurX audit management software.
Key benefits to the organization The AssurX software update keeps all stages of the audit…
(FDA: Silver Spring, MD) -- openFDA is releasing information on medical devices that could spur innovation and advance scientific research.
openFDA’s application program interface expands on the previous openFDA resources concerning medical device-related adverse events and recalls by…
FDA will be taking applications starting Sept 1, 2015, looking for makers of class I and suitable class II medical devices to participate in a pilot program to file malfunction reports in summary form quarterly. Get on the stick, though, if you are interested: there are only nine slots.
Under FDA…
(PQ Systems: Dayton, OH) -- PQ Systems, a Dayton-area quality management software developer, announces new ownership of the company as of June 1, 2015.
Beth Savage, PQ Systems operations manager since 2007, has acquired ownership of the company’s shares formerly held by the family of Michael J.…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has taken important steps to help manufacturers develop biologic products called biosimilars. Biosimilars are highly similar to, and have no clinically meaningful differences from, an already approved biological product.…
(AssurX: Morgan Hill, CA) -- A new FDA guidance issued by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) offers some helpful detail for device firms uncertain if post-approval studies can replace premarket studies at the time of…
(Quality Digest -- Chico, CA) Quality Digest, for more than 30 years the leading source for quality news and resources, is now available on mobile devices. Check out our website on your smartphone or tablet for exclusive content, in-depth articles and columns, industry news, webinars, and more.…
(LNS Research: Cambridge, MA) -- LNS Research, a technology research and advisory firm focusing on the industrial value chain, has released its Environment, Health & Safety (EHS) Research Library. Comprising research-based best practices, benchmark data, and thought leadership publications,…
Michael J. Cleary, Ph.D., founder and president of PQ Systems Inc. and a professor emeritus at Wright State University in Dayton, Ohio, died suddenly on September 10, 2014.
Cleary was born June 3, 1939, in Dumont, New Jersey. He was a graduate of Norwich University and was commissioned as a second…
Commerce Secretary Penny Pritzker has announced that three U.S. organizations will receive the 2013 Malcolm Baldrige National Quality Award, the nation's highest presidential honor for performance excellence through innovation, improvement, and visionary leadership. All of this year's winners are…
(Quality Digest: Chico, CA) -- Are you passionate about quality? Do you want to lead tens of thousands of like-minded quality individuals? Then this job is for you.
The American Society for Quality (ASQ) is looking for a new CEO. According the job posting on ASQ's site:
"The next CEO will lead and…
(NIST: Gaithersburg, MD) -- As most of you have likely heard, the federal government is shutting down due to a lapse in funding. While this will undoubtedly create hardship for many who work for and/or rely on services from the government, I am happy to inform you that the Baldrige Program will…
(Hexagon: North Kingstown, RI) -- Hexagon Metrology today officially unveiled HexagonMetrologyU, the first e-learning portal designed to engage and support the metrology industry. The interactive platform debuts over 30 online courses covering metrology fundamentals, basic and intermediate…
(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…