William A. Levinson’s picture

By: William A. Levinson

The U.S. government’s Fourth National Climate Assessment warns that climate change “creates new risks and exacerbates existing vulnerabilities in communities across the United States, presenting growing challenges to human health and safety, quality of life, and the rate of economic growth.” The same report mentions increased risks of wildfires along with droughts in the Southwest.1 There are numerous financial advantages, regardless of the role of carbon emissions in climate change, to use ISO 50001:2018—“Energy management systems—Requirements with guidance for use” to reduce these emissions, and also to adapt its new clauses to the environmental management system ISO 14001:2015.

NIST’s picture

By: NIST

A convocation of delegates representing 60 countries voted last month in Versailles, France, to implement the most significant change to the International System of Units (SI) in more than 130 years. For the first time, all measurement units will be defined by natural phenomena rather than by physical artifacts. The event was the 26th General Conference of Weights and Measures and was hosted by the International Bureau of Weights and Measures.

Although consumers and most industries will not notice immediate impacts, scientists expect the change ultimately to inspire new technologies and to reduce the cost of calibrating industrial processes and scientific instruments.

6 people standing on a stage in front of a screen that reads: 26th CGPM

NIST’s picture

By: NIST

The U.S. Department of Commerce announced that the 2018 Malcolm Baldrige National Quality Award will be given to two educational institutions, an organ donor group, a hospital, and a project management firm. A presidential-level honor, the award recognizes exemplary U.S. organizations and businesses that demonstrate an unceasing drive for radical innovation, thoughtful leadership, and administrative improvement.

“These awardees are inspiring in so many ways,” says Under Secretary of Commerce for Standards and Technology and National Institute of Standards and Technology (NIST) Director Walter G. Copan. “Each honoree strengthens our economy through its organizational excellence and positive impacts for its customers, students, patients, and employees. They exemplify the American spirit in action and are role models for success in business and commerce.”

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.

“GE’s Lessons Won’t Determine Whether You Succeed or Fail”

Does the success or failure of GE’s CEO really matter that much when it comes to how most of us lead, manage, and plan each day? Not necessarily.

“Top Five Things Life Science Companies Need to Know About ISO and FDA Requirements,” an interview with Matthew Lowe of MasterControl.

If the ISO standard says you “shall” do something you should do it; if the FDA says you “shall” do something, you really, really better do it.

Ryan E. Day’s picture

By: Ryan E. Day

BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life science industry, like BBG, operate in a heavily regulated environment. This is the story of how one company delivers world-class products and stays on the right side of compliance while doing it.

BBG’s subsidiaries are:
• Qualtex Laboratories, which provides state-of-the-art patient, donor, and biological testing services. Qualtex has locations in both Texas and Georgia.
• GenCure, which is a human-tissue and cell-therapy organization, collecting and processing human tissues, umbilical cord blood and tissues, as well as providing cell therapy apheresis services, and contract manufacturing services.
• South Texas Blood and Tissue Centers, which provide blood, plasma, platelets, and other blood components to 67 hospitals in 43 South Texas counties.

The fourth arm of BBG is the Blood & Tissue Foundation, which raises awareness and funds to support the many life-saving activities of BioBridge Global.

Taran March @ Quality Digest’s picture

By: Taran March @ Quality Digest

These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has challenged itself to find ways to enhance efficiency and update old regulations. Quality Digest has kept an eye on the FDA’s progress toward these goals. How well has it done? For a sprawling bureaucracy, marvelously.

One of the first pieces QD published this year was a declaration of intent from FDA chief Scott Gottlieb, who said the agency has recognized “when scientific innovations warrant new, more flexible regulatory approaches.” A number of specific changes that would speed products safely to market have been approved and developed, including harmonizing global standards, supporting electronic submissions, and clarifying and promoting a “least burdensome” approach to premarket reviews. The FDA has also embraced the idea of continuous manufacturing to help drug manufacturers and their customers save money.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell their products in Canada. This mandate could have consequences for Canadian citizens.

What is the Medical Device Single Audit Program?

Is MDSAP one certification accepted by all? No, however it is accepted by five countries: the United States, Canada, Brazil, Australia, and Japan. 

What medical device company that sells internationally wouldn’t want a yearly one-and-done audit that satisfies the regulatory requirements of those five countries? Within the medical device community, where audits are strict and often expensive, the ability to go through a single quality management system (QMS) audit and have those audit results accepted by five countries would theoretically save time and money compared to dealing with each country’s regulations individually. That was the intended goal behind the Medical Device Single Audit Program (MDSAP). However, as is the case with many plans, the unintended consequences may hurt not just the medical device companies it was supposed to help, but in the end may harm consumers.

Mike Richman’s picture

By: Mike Richman

The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That’s the unfortunate reality for weather forecasters, stockbrokers, sports bookmakers, political pundits, and writers of science fiction. Yet people keep trying to project trend lines and read tea leaves, maybe because we like to wonder about the moral and ethical choices that some future state will force us into. Or maybe these kinds of stories just make good copy. Either way, with this article you can add another fool—yours truly—to the list.

The changes to come in most industrial sectors are fascinating to ponder and debate, but in truth few will force us to confront and come to grips with the most essential aspects of our humanity. Sure, self-driving cars, super composites and alloys, molecular computing, and similar breakthroughs are already changing the world, and will continue to do so in the next decade and beyond. Yet few if any of these changes will also change us in any substantive way.

Ryan E. Day’s picture

By: Ryan E. Day

One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years. The FDA has broad jurisdiction to regulate all health products, and it also has the freedom to not exercise that authority (enforcement discretion) as it sees fit. This puts Finch in the delicate position of providing a product that is regulated by the FDA, yet isn’t actually bound by any existing regulatory statutes, such as 21 CFR.

Finch is a clinical-stage microbiome therapeutics company dedicated to developing novel microbial therapies to serve patients with serious unmet medical needs. Built on 30 years of translational research at OpenBiome, MIT, the University of Minnesota, the Center for Digestive Diseases, and Crestovo, Finch uses its unique Human-First Discovery approach to develop therapies from microbes that have demonstrated clinically significant impacts on patient outcomes.

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Matthew M. Lowe’s picture

By: Matthew M. Lowe

Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails. Whether new or established, life science companies share a common need as a prerequisite to success: regulatory compliance.

A new medical product deemed unsafe or ineffective by regulators will never reach patients, no matter how innovative it is. Noncompliance can make or break a regulated company, especially if the violation leads to serious adverse events or a product recall.

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