All Features
Prashant Yadav, Antoine Désir
The pandemic has seen an unprecedented global effort to accelerate the development of safe and effective vaccines as well as a rapid expansion of vaccine manufacturing capacity. However, challenges in further scaling up vaccine manufacturing capacity to meet higher-than-expected demand, and the…
David Gillum, Kathleen Vogel, Rebecca Moritz
The origin of SARS-CoV-2 remains a mystery. One theory is that the coronavirus that causes Covid-19 was transmitted from animals to humans—a fairly common occurrence. Another is that it came from a laboratory accident—a more infrequent circumstance.
Around the world, scientists conduct many kinds…
Julia Canale
Believe it or not, the technology that brought you Bitcoin is beginning to make waves in the food manufacturing industry. This technology, called blockchain, is a digital ledger maintained across several computers, then linked through a peer-to-peer network. The system's design makes it difficult…
Rich Tree
Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full of challenges. The goal is to start up as soon as possible once the project is completed but also to achieve steady-state throughput as quickly as possible after the startup begins. This type…
Taran March @ Quality Digest
In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production. Every day of production seems to create a…
Wade Schroeder
As more medical devices using network-connection technology are developed, cybersecurity will continue to grow in importance and focus among regulators and manufacturers.
Many connected devices store or transmit patient data for which there is an expectation of both privacy and accuracy. Any sort…
Adrian Hernandez, C. Michael White
T
he U.S. Food and Drug Administration (FDA) regularly inspects manufacturing facilities to ensure that drugs meet rigorous quality standards. These standards are vital to protect patients from drugs that are incorrectly dosed, contaminated, or ineffective.
But over the past few years, tens of…
Del Williams
To meet increasingly strict compliance standards, such as the Food Safety Modernization Act (FSMA) and Global Food Safety Initiative (GFSI), food processors now regularly use adenosine triphosphate (ATP) testing to monitor equipment surfaces for microbial growth. Add to this the need to minimize…
Jon Speer
Demonstrating identification and traceability in all quality system processes is a must for medical device companies to comply with FDA regulations. To satisfy this compliance need, companies will need to connect related processes within their quality system to close the loop between related pre-…
Wade Schroeder
Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.
If there’s any “spoiler alert” to this article, it’…
Emily Newton
Food manufacturers must carry out numerous specific processes to check that the foods they produce and distribute are safe for consumers. Analytical testing plays a vital role in meeting that goal. Here’s a look at how such examinations raise food quality and purchaser trust.
Checking foods for…
Janet Woodcock, Judy McMeekin
During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The Covid-19 pandemic required us to rework our business operations so that we could carry out our public health…
Esteve Garriga
There are many important issues to be considered in the food industry, such as consumer tastes, environmental impact, and economic aspects, but the most important is food safety.
Although current food safety management system (FSMS) certification schemes around the world are highly effective, I…
Clare Naden
Never have we been more acutely aware of the importance of reliability when it comes to laboratory testing. As the ongoing Covid-19 pandemic has highlighted, the development of accurate diagnostic tests plays an important role in outbreak management.
Whether a laboratory develops its own test…
Sheronda Jeffries
Since the beginning of the coronavirus outbreak, UK officials have seized millions of substandard face masks at Heathrow Airport. These masks could have put millions at risk for contracting or spreading the Covid-19 virus.
Industry and governmental organizations including the Therapeutic Goods…
Stephen M. Hahn, Amy P. Abernethy
During a short period of time, our society has seen a rapid increase in the interest and availability of cannabidiol (CBD) products and other products derived from cannabis. However, we still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds,…
Richard Harpster
As someone who has helped companies in a wide variety of industries for the last 30 years solve many problems using risk-based thinking, I cannot think of an issue that I have worked on that is more important than preventing the spread of Covid-19. With three high-risk people in my home, I have…
Natalie Weber
Unlike Covid-19, remote audits aren’t unprecedented. Remote audits didn’t start with the pandemic, although it has forced more companies to use them than previously. At MasterControl, we’ve been doing remote audits for years for our international customers. It saves time and expense, and it’s every…
Jon Speer
The medical device industry is one that requires preparation. Unlike less regulated industries, there’s an expectation in the industry around the possibility that an inspector or auditor can show up without notice and stop a business in its tracks.
That’s why, when Greenlight Guru released its “…
Grant Ramaley
IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical device regulators but also recognized by some other regulatory authorities as a regulatory…
Jon Speer
Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk.
Although risk is a variable we encounter in everyday life, it means something uniquely different to the medical device industry.…
Thomas R. Cutler
About one in two U.S. adults has a musculoskeletal disorder, costing an estimated $213 billion each year in treatment and lost wages, according to a report from the United States Bone and Joint Initiative. Musculoskeletal disorders (MSD) are injuries and conditions to the bones, muscles, and joints…
Stephen M. Hahn, Anand Shah
Americans may be surprised to learn that many 21st-century medical products are still being manufactured using technologies commonly employed since the middle of the last century. These manufacturing platforms are not dynamic and can increase the risk of shortages, limit flexibility during an…
Del Williams
Approximately 48 million people in the United States (one in six) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and Prevention. Consequently, the FDA Food Safety Modernization Act (FSMA) is transforming the nation’s…
Leigh Turner
Given the death, suffering, social disruption and economic devastation caused by Covid-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus.
But the U.S. Food and Drug Administration (FDA), charged with the task of evaluating and…
