Day 2 – Wednesday, Nov. 18, 2020
8:00 AM
Welcome and Introduction
8:00 AM - 8:15 AM PST
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
8:15 AM
Do’s and Don’ts for FDA Inspections: Analysis from Former FDA Investigators
8:15 AM - 9:00 AM PST
Hear valuable advice from former FDA investigators who share what to do — and not to do — during and after an inspection. They’ll hash out the best and worst practices they’ve observed when conducting inspections and the steps can you take to avoid the worst practices and embrace the best. You’ll come away with not-to-be-missed steps you can take following an inspection to ensure things go more smoothly during the next one.
David Elder (Panelist)
Executive Vice President
Greenleaf Health
Greenleaf Health
David Chesney (Panelist)
Principal and General Manager
DL Chesney Consulting, LLC
DL Chesney Consulting, LLC
Vicky Stoakes (Panelist)
President
IntegRx, Inc.
Former FDA Chemist ACNA and Former FDA Investigator Atlanta District Office Drug Cadre
IntegRx, Inc.
Former FDA Chemist ACNA and Former FDA Investigator Atlanta District Office Drug Cadre
Steve Niedelman (Moderator)
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
9:00 AM
Break
9:00 AM - 9:15 AM PST
9:15 AM
Three Concurrent Breakout Tracks
9:15 AM - 11:30 AM PST
Track #1: Drugs & Biologics
Track #2: Medical Devices
Track #3: Clinical Trials
11:30 AM
Closing Remarks
11:30 AM - 11:45 AM PST
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
11:45 PM