Auditing, which is independent of and separate from routine monitoring or quality control function, should be to evaluate trial conduct and compliance with SOPs, GCPs and the applicable regulatory requirements.
Incorporating a Quality Assurance component into your company’s Quality System is the start of ensuring that clinical research activities are conducted in compliance to applicable regulations. Auditing is used to verify that compliance.
Auditing can be a powerful tool for finding issues and correcting them as research is being conducted and is preferred over regulatory agencies finding your studies were not conducted properly or in compliance. This webinar will review the general principles about how to audit including preparation, auditing, documentation and follow up.
This webinar will move into how to audit using Good Clinical Practice (GCPs) as the framework within clinical research no matter where the audit takes place including investigative sites, sponsors, or CROs. Then the webinar will close with some information on latest trends in Quality Assurance.
- General principles for auditing
- Steps for preparing and completing an audit
- Framework of using Good Clinical Practices
- Use of Tools and Processes
- Trends in Quality Assurance
- Contract VP’s
- Quality Departments
- Regulatory Affairs Departments
- IT Departments
- Contract Personnel
- GxP Personnel