FDA Compliance Features

Rich Tree's picture
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...
Taran March @ Quality Digest's picture
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...
Wade Schroeder's picture
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...
Adrian Hernandez's picture
Adrian Hernandez
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...
Del Williams's picture
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 (...
Jon Speer's picture
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...
Wade Schroeder's picture
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...
Emily Newton's picture
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....
Janet Woodcock's picture
Janet Woodcock
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...
Esteve Garriga's picture
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...
Clare Naden's picture
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...
Sheronda Jeffries's picture
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...
Stephen M. Hahn's picture
Stephen M. Hahn
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...
Richard Harpster's picture
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...
Natalie Weber's picture
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...
Jon Speer's picture
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...
Grant Ramaley's picture
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...
Jon Speer's picture
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...
Thomas R. Cutler's picture
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...
Stephen M. Hahn's picture
Stephen M. Hahn
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...