I worked for a Chief Quality Officer a number of years ago who always had this response when our company was contemplating movement of a large volume of internal production to third parties: “You can delegate your responsibilities... Read more
Executive Insights from FDLI’s 2015 Enforcement, Litigation & Compliance Conference: Trends and Risks for 2016 and Beyond
Early December is one of my favorite times of year. Coming off of Thanksgiving and looking forward to the end-of-year holidays, it’s when I get to reflect on the past 12 months, and think about what the next... Read more
FDA’s Upcoming Quality Metrics Submission Requirement: Data Driven Decision-Making or Letting the Students Issue Their Own Report Cards?
Although Corporate America has embraced the concept of metrics and dashboards for close to 20 years now, the US Food and Drug Administration (FDA) has only recently come to the conclusion that incorporating a review of company-provided product quality metrics... Read more