Failure to follow the investigational plan, insufficient PI control, and informed consent irregularities continue to rank high on the list of top findings in FDA and EMA inspections.
In this Brunch with GxP auditor, together with our international expert's colleagues, we will look at real-world examples of some of the top inspection findings from 2021 and discuss appropriate CAPAs, providing listeners with solutions to avoid common pitfalls and ultimately, inspection findings in the future.
Correct GCP behavior will be reviewed, and lessons gained
will be utilized to prevent these results from occurring again. Participants are invited to share their experiences as they explore approaches and instruments to help in compliance
via suitable ICH-GCP practices.