July 21, 2016
Doubletree Hotel, St. Louis Park, MN
In February 2016, Dr. Frestedt published her first book: Warning Letters: 2016 Reference Guide. This presentation will review the contents of the book as well as a few pointers on book publishing in response to audience interest. Dr. Frestedt will lead a 1 hour discussion about 483s and Warning Letters including a discussion with audience members about negotiating with FDA inspectors during inspections. Come to learn about each other’s trials and triumphs. The goal is to have an open dialog about getting good compliance and setting up a collegial relationship between regulatory and operational staff. What does it take to stop worrying about a warning letter?
BIO: Dr. Frestedt has managed clinical research, regulatory affairs, and quality systems for more than 35 years and has published more than 100 manuscripts, book chapters and, recently, her first book entitled “Warning Letters: 2016 Reference Guide” with Barnett International. With a PhD in Pathobiology from the University of Minnesota Medical School, her experience includes designing, conducting and overseeing clinical trials as well as negotiating regulatory submissions and developing quality systems for companies like the University of Minnesota, Orphan Medical, Astra Zeneca Pharmaceuticals, Johnson and Johnson, Medtronic, and Mayo Clinical Trial Services. Dr. Frestedt also founded Alimentix, the Minnesota Diet Research Center and was named one of the “100 Most Inspiring People in the Life Sciences Industry” (PharmaVOICE, 2011) and one of the top 25 “Industry Leaders/Women in Business” (Minneapolis/St. Paul Business Journal, 2011).