6 Emerging FDA Inspection Trends

Tuesday, February 17, 2015

Source: MD&DI

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."

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