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Deep Learning AI Discovers Surprising New Antibiotics
Sriram Chandrasekaran
Imagine you’re a fossil hunter. You spend months in the heat of Arizona digging up bones only to find that what you’ve uncovered is from a previously discovered dinosaur. That’s how the search for antibiotics has panned out recently. The relatively few antibiotic hunters out there keep finding…
Critical Data Elements and Data Quality
Rupa Mahanti
We are currently living in the digital age and are drowning in an ocean of data. Organizations have a large number of data entities and data elements, and a large volume of data corresponding to the same, and they continue to amass more and more data with each passing day. With the large amount of…
Manufacturing Standards for Biopharmaceuticals
Sheng Lin-Gibson, Vijay Srinivasan
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,…
Handling Product Recalls and Product Liability Lawsuits
Randall Goodden
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…
Fourteen Leadership Principles That Drive Amazon to Be Customer-centric
Ian Golding
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…
Hospital Rankings Hold Up
Peter Dizikes
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…
Technique Reveals Whether Models of Patient Risk Are Accurate
Anne Trafton
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…
Bridging the ‘Valley of Death’ for U.S. Biomanufacturing
Kelvin Lee
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…
The Four Yokes of the Change Agent
Jim Benson
‘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…
Just Add Engineers to the Mix
Michael Baxter
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…
Five Ways Brands Are Changing Their Playbooks to Win
Knowledge at Wharton
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…
Recent Legislative Impacts to Telemedicine in Care Delivery
Clinton Ballew
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…
Quality Has a Role to Play in Pricing and Should Claim a Seat at the Table
Patrick Moorhead, Gabriel Smith
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…
How to Use Your Data to Drive Real-Time Customer Experiences
Vaishali Gopi
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…
Quality Is Everything
Dirk Dusharme
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…
Quality Digest Top Stories for 2019
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…
An Action Plan for Work-Family Balance
Anat Amit-Eyal
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…
Medical Errors Still Harm Too Many People, But There Are Glimpses of Real Change
Michael Millenson
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 Quizzes for Current Good Manufacturing Practices Training Credit
The QA Pharm
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…
FDA’s Fast-Track Model for Software As a Medical Device Requires a Cuture of Quality
Heather Thompson
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…
Turning the Pharmaceutical Model Upside Down
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…
The Food Safety Modernization Act in a Nutshell
Dileep Thatte
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…
Life Without the Paris Agreement
William A. Levinson
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…
How to Win at Customer Service
Emily Safrin
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…
Big Food Is Ripe for a Revolution
Boris Liedtke
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…

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