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15TH ANNUAL

FDA INSPECTIONS vSUMMIT

Tuesday, Nov. 17 – Wednesday, Nov. 18, 2020

#1 Event for Quality, Compliance and Regulatory Professionals

Virtual Agenda

Day 2 – Wednesday, Nov. 18, 2020

11:00 AM

Welcome and Introduction

11:00 AM - 11:15 AM EST

Steve Niedelman

Lead Quality Systems and Compliance Consultant
King & Spalding LLP
Former FDA Deputy Associate Commissioner for Regulatory Operations
11:15 AM

Do’s and Don’ts for FDA Inspections: Analysis from Former FDA Investigators

11:15 AM - 12:00 PM EST

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

David Chesney (Panelist)

Principal and General Manager
DL Chesney Consulting, LLC

Vicky Stoakes (Panelist)

President
IntegRx, Inc
Former CDRH Chemist
ACNA and Investigator
Atlanta District Office Drug Cadre (Invited)

Steve Niedelman (Moderator)

Lead Quality Systems and Compliance Consultant
King & Spalding LLP
former FDA Deputy Associate Commissioner for Regulatory Operations
12:00 PM

Break

12:00 PM - 12:15 PM EST
12:15 PM

Three Concurrent Breakout Tracks

12:15 PM - 2:30 PM EST

2:30 PM

Closing Remarks

2:30 PM - 2:45 PM EST

Steve Niedelman

Lead Quality Systems and Compliance Consultant
King & Spalding LLP
Former FDA Deputy Associate Commissioner for Regulatory Operations
2:45 PM

Adjournment

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