2019 - Surviving an FDA Sponsor Inspection - Training for Success

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