The United States’ FDA, Health Canada, and the United Kingdom’s Medicines & Healthcare Products Regulatory Agency recently published five guiding principles for predetermined change control plans ...

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a ...

The term “change management” has been bandied about so frequently that it’s starting to lose its heft. We’re flooded with business terms that once meant something but have since been downgraded to ...

At its core, change management is about people. While strategic plans and logistical considerations are critical, the success of any change initiative ultimately hinges on how well individuals within ...