6 Emerging FDA Inspection Trends
Tuesday, February 17, 2015
Increased regulatory oversight in the past year or two has forced quality, regulatory, and compliance personnel to be on their toes. And that's a good thing in terms of ensuring quality and, ultimately, protecting patients and end-users. However, it's not without its headaches—particularly when facing an increasingly demanding and inconsistent inspection environment.
The key to inspection preparedness, however, is to cultivate a culture of quality within an organization rather than a culture of compliance, according to Dennett Kouri, senior director, quality, regulatory, and clinical at Edwards Lifesciences. Kouri, who will be presenting on, "Being audit-ready at all times in an inconsistent inspection environment," at MD&M West on February 11, explains that a culture of quality is characterized by the mindset, "this is how our organization operates on a day-to-day basis under the confines of our quality management system," rather than approaching every day as if, "we're just trying to get ready for the next inspection."