21 July 2016
5:30–8:30 pm
Doubletree by Hilton Minneapolis – Park Place
Minneapolis, MN
Join your regulatory colleagues from across Minnesota for an evening of networking and an expert presentation on 483s and Warning Letters. This meeting is sponsored by the RAPS Twin Cities Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory and quality professionals.
In February 2016, Joy Frestedt, MD published her first book, Warning Letters: 2016 Reference Guide, and this presentation will review the contents of the book, as well as a few pointers on book publishing in response to audience interest. What does it take to stop worrying about a warning letter? Find out as Frestedt leads this one-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.
A light dinner will be available to all meeting participants and attendees may claim two recertification points.
Date/Time:
Thursday, 21 July 2016
5:30–6:00 pm Registration and Check-In
6:00–7:00 pm Networking and Dinner
7:00–8:30 pm Speaker Presentation and Q&A Session
Location:
Doubletree by Hilton Minneapolis—Park Place
1500 Park Place Boulevard
Minneapolis, MN 55416
Directions are available online or by calling +1 952 546 8600
Registration:
Advance Registration (prior to 15 July):
RAPS Members: $45 Nonmembers: $55
Registration (on or after 15 July):
RAPS Members: $55 Nonmembers: $65
Speaker: Joy Frestedt, MD, PhD, CCTI, RAC, FRAPS, president & CEO, Frestedt Inc.
Joy Frestedt, MD, PhD, CCTI, RAC, FRAPS has managed clinical research, regulatory affairs and quality systems for more than 35 years. She 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. 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).
Local Contact:
Lena Cordie, chair, RAPS Twin Cities Chapter
RAPS Contact:
Wesley Carr, senior manager, chapter and volunteer relations, RAPS, +1 301 770 2920