LIVE WEBINAR | September 20, 2PM ET
As a clinical research professional, you are aware of the challenges of inspecting in a complex environment but perhaps would like to learn more about FDA Form 483 consequences. The presentation will provide a brief overview of the current FDA BIMO Inspection process for clinical research sponsors and investigators, and discuss the challenges innate in inspections conducted within the complex, dynamic, medical environment. The skills, qualifications, approaches, and inconsistencies of inspectors can have a huge impact on sites and sponsors.
Using actual examples from inspections, these challenges will be reviewed, including the variability in inspectors deciding to issue (or not issue) a 483.
In addition, the unintended consequences of a resulting 483 will be examined. The speaker will challenge attendees to consider some potential opportunities for improvement to help ensure the FDA BIMO Inspection process yields more consistent, meaningful outcomes.