FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program is a webinar that covers topics such as:
- The Sponsor‘s responsibility in monitoring study conduct
- What does the FDA look at when Auditing/Inspecting a study?
- The nature of adequate oversight of all staff and non-staff
- Components of a sponsor monitoring system beyond SOPs
- How do sites prepare for an audit / inspection
- The importance of Protocol knowledge in preventing errors
- The measures to ensure quality monitoring
FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program 2018 intended for:
- Project Managers
- Senior Management
- QA/Compliance Persons
- CRA Managers
- Clinical Research Scientists (PKs, Biostatisticians)
- Principal Investigators and Sub Investigators
- Clinical Research Associates (CRAs) and Cordinators (CRCs)
- Safety Nurses
- QA / QC Auditors and Staff
- Recruiting Staff
- Clinical Research Data Managers