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 ...

Have you ever faced the daunting task of identifying and prioritizing risks in a project, only to feel overwhelmed by the sheer complexity of it all? Whether you’re managing a multi-million-dollar ...

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 ...

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 ...

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