This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
This webinar will discuss how seemingly insurmountable obstacles to a successful FDA sponsor inspection were resolved and how you can apply these lessons to your next FDA sponsor inspection.
Areas Covered in the Webinar:
FDA inspectional procedures; What sponsor staff are audit targets and how FDA inspections are performed
Sponsor SOP and TMF options that work and do not work toward complying with FDA documentation requirement
FDA sponsor inspection objectives and perspectives
Typical and common FDA questions and how not to respond
The impact of CRO contractual delegation of project responsibilities on sponsor regulatory obligations
Audit of sponsor records and training of sponsor staff as a positive step in preparing for the inspection