Full course description
THIS LISTING IS THE TBA SESSION OF THIS CLASS. To be notified when a session of this class is scheduled, or if you cannot attend the already scheduled course, please enroll in this class.
Can you survive a Food & Drug Administration (FDA) Audit? Come learn how to effectively host an FDA Inspector at your site and actually benefit from the audit experience! Participants will gain an understanding of what is involved in the FDA audit process, how to prepare for an FDA audit, and how to identify what information is important to the FDA. Topics including patient safety and data integrity will be discussed. The program will include a question and answer session with study coordinators who have experienced multiple FDA audits.