Topics
- Audit Vs. Research
- What is clinical Audit?
- Five stages of Clinical Audit
- The Audit Cycle
- What are the risks?
- QA Program factors- implementing a program in place
- Interactive case study to learn about audits
- What a sponsor and investigator need to know about FDA audit?
- Preparing for a site visit
- Tips for a successful study
- Most common FDA violations/actions
Who should Attend
Attendees from Clinical research organization, research sites, biotech and pharmaceutical industries that conduct clinical trials, including Clinical Trial staff and management, Regulatory Affairs, Project Managers, Clinical Development and Drug Safety staff.
