Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!

This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your staff groups.

Also, each quiz will have one letter tile at the bottom. Collect all eleven tiles and unscramble the letters for an important message.

When you have completed all 11 quizzes, you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training. Be sure to document this training according to your established procedures.

An answer key will be provided after the eleventh quiz to use for further discussion.

Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies.

Medical device companies developing these products can take advantage of the FDA’s new programs designed to advance trusted companies so they can get products to market efficiently and effectively.

Equally important, if you want to be part of the SaMD trend and its accompanying regulatory pathway, the FDA is clear: Make sure your quality management system (QMS) is exemplary.

The company Grace Science was born through an inversion of the normal business sequence. Typically, if an entrepreneur launches a startup and it succeeds, the founders will create a nonprofit, declaring, “We want to give back.” In this case, the nonprofit spawned the startup.

The company’s inception accelerated when Matt Wilsey first met with Carolyn Bertozzi in 2015. Bertozzi is the Anne T. and Robert M. Bass Professor of Chemistry and professor of chemical and systems biology and of radiology (by courtesy) at Stanford University.

Wilsey’s daughter, Grace, has an ultra-rare disorder caused by a mutation in a gene known as NGLY1. Only 54 people in the world have been diagnosed with the disease. In 2014, Wilsey and his wife, Kristen, created a nonprofit, the Grace Science Foundation, in their quest to find a cure. The foundation has raised about $9 million to date.

In May 2019, a California jury found Monsanto’s weed killer, Roundup, to be a “substantial factor” in the cancer suffered by a couple and ordered the U.S. agrochemical company to pay them $2 billion in damages. This was the third and largest verdict against Monsanto, now owned by German pharmaceutical giant Bayer, over its decades-old product.

A judge slashed the award to $86.7 million in July 2019 after Bayer appealed, but it is cold comfort for the company. An estimated 13,400 similar Roundup cancer cases are pending in state and federal courts across the United States. European investors and Bayer’s management are in shock at the size of the settlements.

Any patient scheduled for surgery hopes, and maybe assumes, that his surgeon will do a high-quality job. Surgeons know better. Nearly three decades of research have made clear that some hospitals and surgeons have significantly better outcomes than others.

Exactly how to measure the quality of a surgeon’s skills, however, is up for debate. Surgical volume—the number of operations of a specific kind performed at a hospital or by an individual surgeon—is known to be a good marker for quality. But it’s not perfect. For example, looking only at hospitals that perform at least 125 bariatric surgeries per year, a recent review found that the rate of serious complications ranged from less than 1 percent to more than 10 percent.

Technology companies are frequently driven by their engineering processes. Of course product quality is regarded as most important, and that quality can be tested and measured with numbers and data. Such companies also frequently align their core identity with the engineering that belies their innovation. Their top executives often started out as engineers and keep looking primarily through their engineering lens as they become company leaders. Although it makes perfect sense, this approach is misguided.

I didn’t understand what people were asking me when I was a kid. The question would come in several different forms. Sometimes it was, “What are you?” Other times it was, “Where are you from?” I would answer with things I knew to be true, like, “I’m a girl,” or, “I’m a person,” or, “I’m from Maryland,” in a sincere, but failed, effort to satisfy my questioner.

I later came to understand that these people actually wanted to know my ethnicity. I grew up in a stereotypical melting-pot USA kind of place, otherwise known as Howard County, Maryland, where many neighbors and classmates were of various ethnic backgrounds. Even in this melting pot, I was different. I am of mixed ethnicity: My mom’s half is Afro-Caribbean by way of Jamaica, and my dad’s half is East Indian by way of the West Indies. I couldn’t be placed in one bin, and I was keenly aware from the questions I received that I was different. This made me want to understand this “otherness,” and that is what sparked my love of human genetics.

Credit: Mark Esser/NIST

We all expect hospitals to be open and operating when we need them, but extreme weather events like hurricanes are a strain on resources and pose significant challenges for hospitals.

Closing a hospital is an extreme action, but several hospitals in Florida, Georgia, and South Carolina did just that before the arrival of Hurricane Irma in 2017.

With more than 300 hospitals and a higher share of older adults than any other state, Florida had a critical issue facing emergency planners during those storms.

As a professor of urban planning, I have studied emergency planning and evacuation and also co-authored an extensive report on how hospitals coped with the aftermath of Hurricane Katrina and Hurricane Gustav. Hospitals plan for catastrophic events, but there are always lessons to be learned.

Hospitals try to stay open and care for patients already hospitalized as well as those who suffer injury or illness from a storm. Here’s how they do it.

A career as a physician has traditionally been considered to be among the best vocations that talented students can pursue. That may no longer be the case. All too many doctors report that they are unhappy, frustrated, and even prepared to leave the profession.

That should worry all of us. The physician burnout crisis is likely to affect our quality of care and our access to healthcare providers.

According to a recent study, 44 percent of U.S. doctors suffered at least one symptom of burnout, and some studies have identified even higher burnout rates. By contrast, researchers have found only a 28-percent burnout rate in the general working population.

On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU market must have effectively completed the transition from the previous medical device directive and be fully compliant under EU MDR.

This statement alone may be surprising to certain Class I manufacturers, who assume that their products’ classification as low-risk devices under the previous directive will exempt them from all this EU MDR commotion. These presumptions are misguided because classification requirements listed in the EU MDR are relevant to all manufacturers, irrespective of past classification.

With this deadline in sight, it is crucial that all manufacturers familiarize themselves with these regulatory changes and promptly make a start on implementing necessary measures. Those that fail to achieve compliance on time will be left behind, and their products removed from the market. In light of this industry bustle, this article aims to advise Class I manufacturers about the primary alterations that the EU MDR will enforce, as well as offer practical steps that manufacturers can begin to follow.