During FDA drug and device inspections, investigators now ask to see the firm’s system that ensures the accuracy and consistency of its data. When firms fail to have a system, or the system is inadequate, FDA officials issue 483 observations send warning letters.
Come engage with colleagues from the local regulatory community and learn how to avoid the pitfalls associated with data integrity. This event is sponsored by the RAPS DC/Baltimore Chapter and is intended to promote knowledge sharing and connections between regulatory and related professionals in our region.
You should arrive no later than 6:15 to participate in a drawing for special giveaways. A light meal will be provided. RAC holders may claim two RAC recertification credits.