Webinar: Masters Classes in - Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges When: Thursday Apr 29, 2021 - 11:00 AM EDT Duration: 8 Hours.
Is the FDA’s increasing scrutiny on your clinical trials’ data integrity giving you a data migraine? FDA data integrity requirements are among the most stringent within regulated industries, so compliance is quite the challenge. Unless you establish internal competency and assessment programs, you can expect 483s and warning letters to come rolling in. It’s no surprise: the FDA continuously trains its investigators on how to conduct data integrity inspections. The result is inspectors who cite a significant number of data integrity observations during inspections, taking action against companies that commit data fraud or provide false information. Making matters worse, investors and business partners are getting into the act: they’re filing multimillion-dollar class-action lawsuits against firms that misrepresented their compliance with FDA requirements.
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