Surviving an FDA Sponsor Inspection - Training for Success

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.

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

Who Will Benefit:

• CQA
• Regulatory personnel
• Clinical operations, CRA
• Director and upper level pharma research management
• Investigators and research management staff
• Clinical Project Manager
• Regulatory Affairs
• Compliance Manager
• Trial Master File Manager
• Recently Asked Questions:
• For FDA inspection of sites outside of the US, what are some considerations?
• Can you provide some insights about the timing of the FDA inspections after submitting the NDA?