North Texas Chapter: FDA Inspections- Understand the Process & Manage the Consequences
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. We will cover important GCP topics to prepare for audits and regulatory inspections and for addressing inspectional/audit observations. Bring your own GCP questions and dilemmas. Part 2 will employ breakout sessions with hands-on activities to create Corrective & Preventive Actions (CAPAs), utilizing root cause analysis (RCA) procedures to address FDA citations in warning letters, NIDPOEs and 483s.
Speaker:
Janet E. Holwell, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant/Trainer
Event 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
Event Agenda:
- 8:30 a.m, CT – Log in
- 9:00 a.m., CT – Presentation
- 10:45 a.m., CT – Q&A
Registration Information:
Click here to register for the event.
Contact Hour Information:
This event will offer 2 contact hours. Click here to purchase contact hours. Please purchase and retrieve your contact hours before August 30, 2023
- Chapter Members: $0
- ACRP Members: $15
- Non-Members: $30
To receive contact hours: Purchase the contact hours and attend the program. After attending the event, log on to the ACRP website and visit learning.acrpnet.org/my/. Select your event, confirm attendance and take the event evaluation between 1 and 30 days following the event and obtain the online certificate." After 30 days, contact hours are no longer available.