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 .
Surviving an FDA Sponsor Inspection - Training for Success 2019 covers topics such as:
- 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
Surviving an FDA Sponsor Inspection - Training for Success 2019 intended for:
- 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