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Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases. Biologics are chemically and structurally complex, and often highly heterogeneous; therefore,…
The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the United States. With all of this growth, it is also apparent that many manufacturing corporations are…
During the last five years, a small number of organizations have been featured multiple times in my writing. In the vast majority of cases, I have used these businesses as a way of bringing to life global best practices in the field of customer experience management.
It is inspiring to be able to…
Given the complexities of healthcare, do basic statistics used to rank hospitals really work well? A study co-authored by MIT economists indicates that some fundamental metrics do, in fact, provide real insight about hospital quality.
“The results suggest a substantial improvement in health if you…
After a patient has a heart attack or stroke, doctors often use risk models to help guide their treatment. These models can calculate a patient’s risk of dying based on factors such as the patient’s age, symptoms, and other characteristics.
While these models are useful in most cases, they do not…
Biopharmaceutical manufacturing uses living cells to produce therapies that treat diseases like cancer, diabetes, and autoimmune disorders. Manufacturing medicine using biology presents different challenges from the traditional chemical manufacturing processes that stamp out identical pressed pills…
‘It’s the shoes!” Spike Lee yelled into the camera on the Air Jordan ads.
But it was never the shoes. Michael, Magic, and LeBron would have outplayed their leagues in golf cleats.
It was never the shoes.
But it was us, the salespeople. In our case, the intelligencia that “trains” people to be…
You would expect a building where vinegar is made to have a sour smell, highly pungent, perhaps with a whiff of apple. World Technology Ingredients (WTI) smells nothing like this. Their manufacturing facility, off a county two-lane in Jefferson, Georgia, has a vaguely mineral aroma. More dry than…
Have you heard of a media company called T-Series? Chances are, you probably haven’t. Gulshan Kumar, whose résumé up to 1983 read, “Fruit juice seller, streets of New Delhi,” founded it that year. Since its inception, T-Series has become an unlikely media powerhouse—its YouTube channel has 119…
Legislative support is growing for the reimbursement of care delivery via telemedicine. The Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General have recently made final and proposed rule changes to stimulate greater use and access for telemedicine delivery. These…
According to the Journal of Consumer Research, a high price indicates either bad value or good quality, whereas a low price indicates either good value or poor quality.
At the heart of this dichotomy is the role that quality plays in both the actual and perceived price of the product. To…
According to the Journal of Consumer Research, a high price indicates either bad value or good quality, whereas a low price indicates either good value or poor quality.
At the heart of this dichotomy is the role that quality plays in both the actual and perceived price of the product. To…
Data, analytics, surveys, IoT, artificial intelligence, and automation are the leading buzzwords in retail and customer service. But what is the point of having all these data about our customers? The business implications can be overwhelming and never lead to anything meaningful.
However, for…
What a year.
No matter your job, your industry, or your political beliefs, this year has been a heck of a ride. The (still ongoing) trade war with China, manufacturing gains (and losses), the 737 MAX, Hong Kong riots, North Korea, Brexit, impeachment. What a mixed bag of ups and downs that has…
As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations. It’s always fun to see what readers gravitate to, and this…
Eric, a 40-something married father of three, runs a successful startup. Given his demanding career, he and his wife decided she would be a stay-at-home mum. Eric believed the attention he devoted to his family was adequate, and that he had fully harmonized his work as CEO and life as a family man…
In late November 1999, a TV producer called me about an alarming report that 44,000 to 98,000 Americans were being killed each year by preventable errors in hospitals, and another 1 million were being injured. Could that be true? Based on my research, I replied, the estimate seemed low.
The “To…
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…
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…
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…
According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means one in six people in the United States get sick from contaminated food every 12…
How will the United States’ withdrawal from the Paris Agreement affect greenhouse gas emissions? Quality Digest editor in chief Dirk Dusharme and Mike Richman, principal at Richman Business Media Consulting, point out that most manufacturers already recognize that waste, including waste of energy…
When Scarlett hung up the phone, she was close to tears. Even more unexpectedly, so was the customer service representative on the other end. How did a seemingly simple inquiry end in two people so frustrated they were on the verge of a breakdown?
Scarlett had called to resolve a mistaken charge…
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…
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…