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OECD Data Integrity US and International Compliance

November 17, 2022 @ 11:00 am - 12:30 pm

OECD Data Integrity
US and International Compliance

1.5 CE Contact Hour
Location: ZOOM Webinar
Speaker: Eric Pittman, Director, Bioresearch Monitoring Division (West) at the US Food and Drug Administration, Greater Chicago Area

Moderators: Allison Oliva, OCRA Professional Liaison

During this presentation, Director Pittman will review and discuss FDA’s perspective on demonstrating compliance for US based studies that are also intended for submission in other OECD countries. The Organization for Economic Co-operation and Development (OECD) is a unique forum where the governments of 37 democracies with market-based economies collaborate to develop policy standards to promote sustainable economic growth.

OECD Document Number 22: Advisory Document of the Working Party on Good Laboratory Practice on GLP Data Integrity, issued Sep 2021. At the conclusion of the presentation, you should be able to access and understand the contents of Document Number 22 and apply the principles of Data Integrity to your systems.

Learn about Monitoring Authority’s implementation and enforcement examples. For instance,  in the US a study may claim compliance prior to inspection by the US Monitoring Authorities; once a study is submitted, it may trigger an inspection, where no compliance certificate is issued. However, in other OECD countries, test facilities must be inspected and certified by Monitoring Authorities prior to study initiation.

The US is an OECD member country and signatory to the OECD GLP Mutual Acceptance of Data (MAD) system. This enables data acceptance between the US and all other OECD member countries. As part of the MAD system, the EPA and FDA share results of their inspections with other OECD countries. Review FDA’s perspective on demonstrating GLP compliance for US based studies that are also intended for submission in other OECD countries. Time will be provided for questions.

 


Eric Pittman

Director, Bioresearch Monitoring Division (West)
US Food and Drug Administration
Greater Chicago Area

Eric started his career with the Agency as a Counter Terrorism hire in 2002 in the Chicago District Office.  While in Chicago he worked many high-profile cases within medical products and food. In 2007, he became the Resident in Charge of the South Bend, IN Resident Post. He continued to work in all commodity areas in both the foreign and domestic arena.  In 2010, he returned to the Chicago District as a Supervisor and in 2011, won the FDA Supervisor of the Year Award.  He became a Branch Director in ORA HQ in 2012 and created the brand-new Produce Safety Network in response to the Food Safety Modernization Act. In 2014, Eric became a Division Director in HQ and in 2018 moved to his current position as the Program Division Director for Bioresearch Monitor.  Eric is currently stationed in Chicago and has the honor of leading a very talented group of investigators and administrative professionals in the division which stretched from Detroit to Hawaii and American Samoa. Eric studied pharmacy and radiological physics in his undergraduate studies and has an MBA with a specialization in Leadership.

 


Moderator:

 Allison Oliva, RAC, OCRA Professional Liaison
Comprehensive Clinical Consulting
aloliva@cccpsg.com


COSTS:
OCRA Members and Non-OCRA Members: FREE
Certificates of attendance will be emailed after the event.

Questions? Contact program@ocra-online.org
OCRA’s non-profit Federal Tax ID# 33-0630455

REGISTER NOW

Registration should be made in the name to be used on the certificate of completion

 

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www.valgenesis.com

Details

Date:
November 17, 2022
Time:
11:00 am - 12:30 pm
Event Categories:
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