As defined, the Clinical Quality Audit is the process for improving the overall quality standard of clinical performances against the established standards. To evaluate trial conduct and compliance with SOPs, GCPs and the applicable regulatory requirements auditing needs to be independent of and separate from routine monitoring or quality control functions. It is paramount to incorporate a Quality Assurance component into your company’s Quality System. This is pivotal to ensuring that clinical research activities are conducted in compliance with applicable regulations. Auditing is used to verify and validate compliance. Clinical Auditing can be a great tool for discovering issues and rectifying them in ongoing research projects. Rather than have regulatory agencies inspect finding your studies were not conducted properly or in compliance, an audit is a preferred alternative. How do you conduct an effective audit that will be reviewed in this webinar which will include preparation, auditing, documentation, and follow-up? This webinar will then move onto 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. Finally, the webinar will close with some information on the latest trends in Clinical Quality Assurance.

Areas Covered in the Session:-

• General principles for auditing
• Steps for preparing and completing an audit
• The framework of using Good Clinical Practices
• Use of Tools and Processes
• Trends in Quality Assurance

Who Should Attend:-

• CEO’s
• Contract VP’s
• Quality Departments
• Regulatory Affairs Departments
• IT Departments
• Contract Personnel
• GxP Personnel
• Consultants