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Handling Stressful Situations During FDA Inspections: What to Do When FDA Knocks on your Door

February 23 @ 12:00 pm - 1:30 pm

Feb 23rd, 2022
12:00 PM-1:30 PM  PST

Educational Opportunity

Handling Stressful Situations During FDA Inspections:

What to Do When FDA Knocks on your Door

Feb 23, 2022

12:00-1:30 pm PST

1.5 CE Contact Hour

Location: ZOOM Webinar

Speaker: Nancy Singer, JD, LLM, RAC, FRAPS

Moderator: Dr. Susan Bain, OCRA President

Panelists : Dr. Susan Bain

Allison Oliva, OCRA Professional Liaison

Tommi Papson, Programs/Past president

Synopsis: During a high-energy, interactive session, the attendees in polls or during breakout sessions will be asked to comment on how they would respond to challenging regulatory situations they might encounter during an FDA inspection. Then a panel of experts consisting of Nancy Singer, Compliance Alliance, Dr. Susan Bain, former FDA Investigator, and current USC Professor, Tommi Papson, Former FDA Investigator and Consultant, and Allison Oliva, Clinical Consultant will provide their guidance and advice.

Nancy Singer, JD, LLM, RAC, FRAPS, is president of Compliance-Alliance LLC. She is an adjunct assistant professor at the George Washington University School of Medicine and Health Sciences. She presently teaches classes for FDA Staff Colleges and FDA District Offices. Previously, she served as special counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney in the honors program with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently, she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy serves on the Boards of Directors for the Regulatory Affairs Professional Society and the Association of Food and Drug Officials. She is a retired commander in the Navy Reserve.

COSTS:
OCRA Members: $10.00
Non-OCRA Members: $10.00 

Certificates of attendance will be emailed after the event.

Registration deadline is FEB. 22nd 2022. 

There is no same day registration.

Questions? Contact program@ocra-online.org

OCRA’s non-profit Federal Tax ID# 33-0630455

 

The name used on registration will be used on the certificate

REGISTER NOW 

Details

Date:
February 23
Time:
12:00 pm - 1:30 pm