Day 1 – Tuesday, Nov. 17, 2020
Welcome and Introduction
King & Spalding LLP
Former FDA Deputy Associate Commissioner for Regulatory Operations
Keynote Address: The FDA Perspective on Inspections: What’s Happening Now and What to Expect in 2021
Do you know how to adjust your processes to ensure inspectional readiness? Hear the latest plans and initiatives coming out of FDA so you can be better prepared.
Elizabeth Miller, Pharm.D.
Office of Regulatory Affairs, FDA
Three Concurrent Breakout Tracks
Track #1: Drugs & Biologics
Track #2: Medical Devices
Track #3: Clinical Trials
What’s a Regulatory Meeting and How Do You Prepare for It?
When the FDA asks you to attend a regulatory meeting concerning compliance issues, will you know what to do and what that means? Do you know how to prepare for a compliance meeting and what will happen? Do you know the possible outcomes of a regulatory meeting on compliance issues? This is the way to stay compliant.
Steve Niedelman (Speaker)
Regulatory & Quality Solutions (R&Q)
Cynthia Schnedar (Speaker)
Former Director of CDER’s Office of Compliance
The Second City
The world's premier comedy club, comedy theater, and school of improvisation will perform a 45-minute live show to help us unwind at the end of the day.