Clinical Trials Audit Proof Monitoring Programs
Friday, May 31, 2013 from 10:00 AM to 11:30 AM (PDT)
Palo Alto, CA
This clinical trial audit training will explain how to identify gaps and risks when preparing for regulatory inspections of sponsor monitoring programs by understanding the components of a clinical trial quality monitoring system.
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.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.