North Texas Chapter: Root Cause Analysis and Corrective and Preventive Actions (CAPAs)
Please click here to purchase contact hours.
- Janet Holwell, CCRC, CCRA TIACR, FACRP/ Clinical Research
- 8:30-9:00 am Log on and ensure connectivity
- 9:00-12:00 am - Presentation, Questions and Answers
Managing compliance in clinical research is vital to successful clinical trials. Regulatory authorities expect that all stakeholders identify noncompliance, perform root cause analysis, put corrective and prevention action in place and then evaluate the effectiveness of the intervention. Without root cause analysis, interventions cannot be effectively identified and designed. This presentation will delineate the scientific concepts of root cause analysis and apply them specifically in the clinical trial setting. There will be a hands-on activity using tools provided.
- Understand how to use RCA tools to support quality system execution
- Identify a possible cause, evaluate it against facts and differentiate facts from assumptions
- Implement Gilbert’s Behavioral Engineering Model for a diagnostic root cause analysis process
- Assess proposed Corrective and Preventive Action Plans (CAPA) for adequacy once the root cause is identified
- Project Managers
- Regulatory Affairs/Compliance
- Data Managers (Site, Sponsor, CRO)
- Medical Monitor, Medical Officer, Project Physician
- Quality Assurance
- Clinical Research Administrators
Contact hours: 3act hours have been applied for through ACRP.
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Refund Policy: Not applicable
Level: Basic to Intermediate