Feb 28, 2022 | Foods, Issue of the Month
By Shawna Lemke, EAS Independent Consultant The noble pursuit of ensuring food safety is as old as time. Historians find evidence as far back as ancient Egypt and Rome of dietary laws, labeling and inspections put in place at least in part to address food safety. In...
Feb 22, 2022 | Drug and Device Corner, Drugs, Medical Devices
FDA’s New Draft Rule: “Medical Devices; Quality System Regulation Amendments” On February 22, 2022, FDA published a proposed rule that aims to harmonize the current Quality System Regulation for Medical Devices under 21 CFR part 820 with international standards, ISO...
Feb 11, 2022 | Dietary Supplements, Drugs, Extra Article
Aligning Operations and Quality Drives Down Costs While Improving Efficiency By Mike Hughes, EAS Independent Consultant Have you ever felt like your co-workers are at a different company? Maybe, even a competitor who is trying to run you out of business? Yup – I have....
Jan 26, 2022 | Foods, Issue of the Month
By Nancy Higley, EAS Independent Consultant Continuous learning supports both business and employee goals. When you hire an employee, you are hiring an asset capable of continuous growth. An educated professional can be a point of difference for your business. There...
Jan 25, 2022 | EAS in Action, Veterinary
EAS consultant Carolyn Kennedy provided the keynote address at the American Feed Industry Association (AFIA) conference during the International Production and Processing Expo (IPPE) in Atlanta. Speaking on human grade pet food, she discussed submissions, labeling,...
Jan 24, 2022 | Drug and Device Corner, Drugs, Medical Devices
Reminder: CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 For application holders filing eCTD...
