Overview of Data Integrity (4of11) GCP Data Integrity Workshop

MHRA’s Expert GCP Inspector Gail Francis discusses how to approach data integrity based on risk; related to
criticality of the data, how organisational culture can affect data integrity, and how lack of control of data integrity can lead to findings on inspection.
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Upcoming training and free continuing education credits: https://www.fda.gov/cdersbia

CDER SBIA 2018 Playlist:    • 2018 CDER Small Business and Industry...  
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