Laurel Thoennes @ Quality Digest’s picture

By: Laurel Thoennes @ Quality Digest

Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?

1988: Food and Drug Administration Act
Officially establishes the FDA as an agency of the Department of Health and Human Services and broadly spells out the responsibilities for research, enforcement, education, and information

1988: The Prescription Drug Marketing Act
Requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade, or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.

The goal of any honest pharmaceutical company is to make money producing a safe product that consumers need and getting it to market as quickly as possible. But the U.S. Food and Drug Administration’s (FDA) job is to make sure drugs are safe, and that means oversight (some would say excessive oversight), and oversight means costs and delays for manufacturers.

The FDA isn’t blind to this issue. In an October 2005 FDA/ISPE workshop, Dr. Janet Woodcock, director for the FDA Center for Drug Evaluation and Research (CDER) stated that a common goal of industry, consumers, and regulators was to have a “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight.”1

Graham Freeman’s picture

By: Graham Freeman

Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries are frequently the result of fatigue, workplace pressure, and the pressure from extra work due to quality failures.

Among the important elements of people, processes, and tools, people are the primary point of failure in increasingly automated systems. Unlike machines, we are subject to fatigue, information overload, and stress that can have a serious impact on our ability to work safely and efficiently. However, people are also where dynamic sense-making, decision-making, and situational awareness reside, which are vital ingredients in complex and high-reliability organizations (HRO).

The aviation industry represents the best example of an HRO, in which automated systems such as navigation and air traffic control are integrated with highly developed human competencies. As a result, the industry sees an extremely small number of safety violations relative to the millions of hours of commercial aviation operation annually.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of the current U.S.-China trade war. Does China really care, and where do U.S. multinationals go from here? Also, a quick look at Conformance Manager, a web-based management system software. Stop using Excel to manage your management system.

“U.S.-China trade relations: What are some options for U.S. companies that manufacture in China?”

Stanley Chao lays out some interesting options, from hiring a Chinese CEO to moving your production to another country.

Tech Corner: Conformance Manager

Mike Richman’s picture

By: Mike Richman

One of our favorite things on our show is to welcome guests, either via Skype or live in the studio. And this week, we were joined by three of our great partners. Here’s a closer look:

Interview: Nicole Radziwill of Intelex

Radziwill is quality manager and data scientist along with the presenter of the upcoming webinar, “SPC and FMEA: Integrating Systems Thinking Into Your Quality Architecture to Drive Improvement.” In this interview, she discusses how to utilize tools to drive quality outcomes for organizations.

Interview: Dan Jacob of LNS Research

Jacob is a research analyst and a perceptive student of quality trends. In this interview, he talks about the state of quality 4.0 initiatives for those within the all-important life sciences sector.

Tech Corner: iWave2 Handheld Wireless Gauge with AR

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.

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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.

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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.

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