Surviving an FDA Sponsor Inspection - Training for Success 2019

Surviving an FDA Sponsor Inspection - Training for Success 2019 is an event dedicated to case study derived from actual inspections wherein FDA performed a sponsor site inspection .

Topics

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

Who should Attend

• CQA
• Clinical operations, CRA
• Regulatory personnel
• Investigators and research management staff
• Director and upper level pharma research management
• Regulatory Affairs
• Clinical Project Manager
• Trial Master File Manager
• Compliance Manager