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Strategic Partner

July 17, 2018 - July 17, 2018

Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

United States

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Event Details

Begins: July 17, 2018

End: July 17, 2018

Event Location: United States

Website: https://www.compli..4806-prdw

Event Organizer

Event Organizer: ComplianceOnline

Contact Person: Sreeraj Mathilassery

Phone Number: +1-888-717-2436

Website: https://www.complianceonline.com/

Overview

This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity

Why Should You Attend:

In today's strict regulatory environment it is more important than ever for companies and individuals to understand and apply good data integrity practice to comply with FDA regulatory requirements and the new draft guidance.

This session will be presented by R. Godshalk, who served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). Prior to joining FDA he worked as research engineer for 10 years.

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