QUOTED. Jan. 25, 2019. David Shore.
Having the right subject matter experts on hand day or night is critical to acing a US FDA facility inspection, Eli Lilly quality director David Shore says. See his remarks here.
"[During an inspection] there's an expectation that you have experts across the globe who can speak to every process. Telling an investigator that they have to wait a whole day to talk to an expert typically isn't well received. But it can be difficult to make sure you have the right people to talk to the investigators and make sure you’re getting across your true intent." –David Shore, quality director, Eli Lilly & Co.
- Find out more: Compliance Corner: In Today's 24/7 World, Have Experts On Call For FDA Inspections, Eli Lilly Quality Director Says
Click here for a free trial of Medtech Insight