Why Should You Attend:
The sponsor clinical operations staff guided the sponsor and investigator site staff through the FDA inspection/audit process. The result was a passed FDA sponsor inspection and approved NDA. There were no FDA warning letters issued to any investigators.
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
The sponsor clinical operations staff guided the sponsor and investigator site staff through the FDA inspection/audit process. The result was a passed FDA sponsor inspection and approved NDA. There were no FDA warning letters issued to any investigators.
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
