Editorial
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.
Objectives
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
Program
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FDA inspectional procedures; What sponsor staff are audit targets and how FDA inspections are performed
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Sponsor SOP and TMF options that work and do not work toward complying with FDA documentation requirement
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FDA sponsor inspection objectives and perspectives
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Typical and common FDA questions and how not to respond
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The impact of CRO contractual delegation of project responsibilities on sponsor regulatory obligations
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Audit of sponsor records and training of sponsor staff as a positive step in preparing for the inspection