Corrective and Preventative Actions or CAPA, is an internal means of achieving Voluntary Compliance, which is the FDA's ultimate objective for clinical research organizations. By implementing a CAPA Program you are demonstrating your commitment to Compliance and Continuous Improvement, which is an on-going process of education, process definition, assessment, prevention, and correction.

No process is perfect and noncompliance may occur, but you must address this noncompliance through a CAPA process in order to achieve Voluntary Compliance. Learn the full elements of CAPA, including the following, as well as reference to our Norton Audits-Specific CAPA Standard Operating Procedure.

Our CAPA Moto: Assess to Measure, Measure to Correct, Correct to Prevent, Prevent to Achieve

1. Difference between Reactive and Proactive Compliance
2. Evaluating, Measuring and Controlling Clinical Investigator Operations
3. Define the CAPA Process and Steps
4. Define Compliance and Noncompliance with respect to federal regulations
5. Investigator Responsibilities for pharmaceuticals and medical devices
6. Importance of Voluntary Compliance with respect to deliberate or repeated noncompliance
7. CAPA Responsibilites and the Study Team Members
8. Importance of Delegation of Authority with a CAPA Process
9. Confidentiality of CAPA Records with respect to internal and external bodies
10. Using a CAPA Assessment Log
11. The Operations, Facilities, Documents, and Human Reserach Subject Systems covered by CAPA
12. How Monitoring Follow-Up Letters feed the CAPA Process
13. Directed or For Cause CAPA Assessments
14. Using CAPA Forms and Plans

Approximately 35 Minutes of Education for all Clinical Research Professionals
No Contact Hours or CEUs issued with this course
Free One-Day Access