All News
(ANSI: Washington, D.C.) -- The American National Standards Institute (ANSI), a recognized accreditation body under the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), encourages relevant stakeholders to utilize the FDA’s Voluntary Qualified Importer Program (VQIP)…
(CBI UBM: Burlington, MA) -- IVT Network, the trusted source for life sciences validation and compliance knowledge, is featuring its flagship event, the 24th Annual Validation Week Oct. 22–24, 2018, in San Diego. Melanie Demakis, IVT’s senior conference producer, recently worked with Connie Hetzler…
(ISO: Geneva) -- The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, announced its intention to use ISO 13485 as the basis for its quality system legislation.
The International Organization for Standardization’s (ISO) international standard, …
(Sparta Systems: Hamilton, NJ) -- A recent survey sponsored by Sparta Systems and conducted by Pharmaceutical Technology, found that while compliance remains the top objective in 2018 among 73 percent of pharmaceutical executives, performance-oriented objectives were nearly as critical for the…
(IVT Network: Burlington, MA) -- The Institute of Validation Technology (IVT) Network, a part of UBM plc, announces the launch of its hands-on, interactive “Quality Risk Management and Change Control” training, taking place Feb. 27—March 1, 2018, in San Diego.
The event is focused on providing…
(ETQ: Farmingdale, NY & Palo Alto, CA) -- EtQ, LLC, a global leader in quality management system (QMS) and environmental, health, and safety (EHS) software has announced that it has been acquired by TCV, one of the largest technology focused growth-capital firms. TCV brings significant…
(FDA: Silver Spring, MD) -- The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combination products using such therapies. Examples include genetically-…
(FDA: Washington, D.C.) -- The U.S. Food and Drug Administration (FDA) has awarded a total of $21.8 million to support 42 states to help implement the FDA Food Safety Modernization Act (FSMA) produce-safety rule. The rule, which the FDA finalized in November 2015, establishes science-based minimum…
(FDA: Washington, DC) -- During the last few months, we’ve shared what the FDA is doing to improve the review of combination products, including establishing the Combination Product Council and identifying necessary process improvements through lean mapping of the combination product review…
(ANSI) -- The Food and Drug Administration (FDA) is requesting feedback on the use of the term “natural” in food labeling. The action is a response to consumers who have requested that the administration explore the use of this term on food labels, considering the changing landscape of food…
(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…
