North Texas Chapter: Root Cause and CAPA Tools for Audit and FDA Inspection Observations
Event Description:
This very interactive session is intended for experienced professionals who deal with complex issues, need to understand the latest developments, and can contribute their own experiences. The presenter will cover important GCP topics to prepare for audits and regulatory inspections and for addressing inspectional/audit observations. The presentation will be followed with hands-on activities to create Corrective and Preventive Actions (CAPAs), utilizing root cause analysis (RCA) procedures to address FDA citations in warning letters, NIDPOEs and 483s. Tools will be provided and participants will work in groups. The session provides an opportunity to collaboratively hone skills in problem solving and root cause analysis resulting in effective corrective and preventive actions.
Speakers:
- Janet Holwell, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant/Trainer
Learning Objectives:
- Describe at least 3 regulatory actions FDA can take following an inspection
- Discuss appropriate strategies for responding to inspection findings
- Implement realistic and appropriate corrective and preventive actions to successfully resolve inspection findings
Registration Information:
- Chapter Member: $0
- ACRP Member: $0
- Non-Member: $0
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
The educational portion of this event may be self-reported as 2 points toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.