Northern California Chapter: Taking the Fear Out of an FDA Inspection
Event Description:
Glenda Guest has an extensive background in the clinical research industry. Through proper preparation, she will guide us toward taking the fear out of an FDA inspection.
Speakers:
Glenda Guest, BS, CCRA, RQAP-GCP, TIACR, FACRP, ACRP-MDP
Event Learning Objectives:
- Identify FDA forms and documents related to an FDA inspection
- Apply successful approaches to prepare for an FDA inspection
- Discuss similarities and differences between audits and FDA Inspections
- Implement realistic and appropriate corrective and preventive actions to successfully resolve audit or inspection findings
Event Agenda:
5:45 - 6:00 - Zoom Check-In
6:00 - 6:05 - President’s Welcome
6:05 -6:10 - Speaker Intro
6:10 -7:00 - Speaker Presentation
7:00 -7:10 - Q&A
7:10- 7:30 - Optional Networking (Breakout rooms)
Registration Information:
Click here to register for this event
- Chapter Member: $0
- ACRP Member: $5
- Non-Member: $10
Contact Hour Information:
This event will offer 1 contact hour. Click here to purchase contact hours. Please purchase and retrieve your contact hours before July 15, 2023.
- Chapter Member: $0
- ACRP Member: $15
- Non-Member: $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, click “GO TO MY COURSE”. 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.