Risk Management
Geopolitical risk is emerging as one of the greatest challenges facing domestic and international business today. It has risen from a boardroom issue to one drawing the awareness and attention of both personnel and the general public. These days everyone knows the word “supply chain” and has…
This current job market is plagued by fake job postings that have been misleading American job seekers, wasting their time and distorting employment data. These deceptive listings—often created to collect résumés, inflate company growth metrics, or manipulate job market statistics—erode trust in…
Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out.
Greenlight Guru invited Vincent Cafiso, a former FDA investigator, to the Global Medical Device Podcast to…
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech…
After spending years working alongside frontline manufacturing teams, I’ve come to see one thing clearly: Preventing incidents isn’t just a legal requirement. It’s the heartbeat of a healthy operation. With workplace safety making headlines daily—often with tragic details—it’s time to highlight…
Established pharmaceutical facilities play a pivotal role in public health by ensuring the safety and efficacy of the medications they produce. This critical responsibility demands strict adherence to the Code of Federal Regulations, including 21 CFR 211.67—“Equipment cleaning and maintenance,”1…
