Clinical Trials Audit Proof Monitoring Programs
Why Should You Attend:
In the current regulatory climate, sponsors should anticipate more FDA sponsor GCP inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site without relying on the “star performer.” Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of vendors, as well as other areas. In this Webinar the components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections of sponsor monitoring programs.
Areas Covered in the Seminar:
- Discuss Sponsor monitors program.
- Identify components of a sponsor monitoring system: beyond SOPs.
- Distinguish each component’s suggested elements.
- Define adequate oversight of non-employee performers.
- Identify other measures to ensure quality monitoring.
- Evaluate gaps monitoring systems.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, and CROs Conducting Clinical Trials including:
- Sponsor Senior Management
- Project Managers
- CRA Managers
- QA/Compliance
- CRAs
