The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method. According to the modern ...
Tracy Harding, CPA, was on his way to work and looking forward to completing an audit he was working on. But on the way in, he heard a news report that changed the objective of his day. A local ...
With the growth of automation and increase of workers engaging with machines, I felt there would be some benefit to sharing an example of the safety risk assessments that we do in order to reduce or ...
Julia Kagan is a financial/consumer journalist and former senior editor, personal finance, of Investopedia. Chip Stapleton is a Series 7 and Series 66 license holder, CFA Level 1 exam holder, and ...
This article is part of PharmTech's supplement "Injectable Drug Delivery." Aseptic processes are some of the most difficult processes to conduct in the pharmaceutical industry. Because of the nature ...
Risk assessments allow you to identify and prepare for any events that may disrupt the daily operation of your business. This should include all the risks relating a project, activity or organisation ...