FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program 2018

Topics

• 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

Who should Attend

• 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