Day 1 – Tuesday, Nov. 17, 2020
10:00 AM
Welcome and Introduction
10:00 AM - 10:15 AM CST
Steve Niedelman
Lead Quality Systems and Compliance Consultant
King & Spalding LLP
Former FDA Deputy Associate Commissioner for Regulatory Operations
King & Spalding LLP
Former FDA Deputy Associate Commissioner for Regulatory Operations
10:15 AM
Keynote Address: The FDA Perspective on Inspections: What’s Happening Now and What to Expect in 2021
10:15 AM - 11:00 AM CST
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.
Assistant Commissioner Medical Products & Tobacco Operation
Office of Regulatory Affairs, FDA
Office of Regulatory Affairs, FDA
11:00 AM
Break
11:00 AM - 11:15 AM CST
11:15 AM
Three Concurrent Breakout Tracks
11:15 AM - 1:30 PM CST
Track #1: Drugs & Biologics
Track #2: Medical Devices
Track #3: Clinical Trials
1:30 PM
What’s a Regulatory Meeting and How Do You Prepare for It?
1:30 PM - 2:00 PM CST
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)
Executive Director and CER Business Unit Lead
Regulatory & Quality Solutions (R&Q)
Regulatory & Quality Solutions (R&Q)
Cynthia Schnedar (Speaker)
Executive Vice President
Regulatory Compliance
Greenleaf Health
Former Director of CDER’s Office of Compliance
Regulatory Compliance
Greenleaf Health
Former Director of CDER’s Office of Compliance
2:00 PM
Virtual Social Event — Beer and Cheese Tasting
2:00 PM - 2:45 PM CST
You’ll receive a sampling of craft beer and fine cheeses in advance of this enjoyable and entertaining session. An expert will talk us through the pairings via Zoom.