Meeting date: March 16, 2021, 12: 00 PM ET
In part two, we learnt how CSA can be adapted to benefit your organization and the application to Data Integrity. Beyond the conversation of ALCOA and ALCOA+, the panelists discussed data integrity challenges the industry is facing and the importance of controls around application-related data followed by several of the most common FDA non-compliance findings, where the DI guidance may not have covered.
Authors:
Francisco Vicenty, FDA
Stephen Cook, CG
Ken Shitamoto, GILEAD
Khaled Moussally,CG
