Canada Chapter: Knock, Knock, FDA is Here- Be Prepared for a Regulatory Inspection
Event Description:
Join us for a discussion of FDA approach and goals during site inspections with comment on Canadian applications specifically.
Speaker:
Mr. Eric Pittman, MBA
Division Director for Bioresearch Monitoring Division III
US Food & Drug Administration
Event Agenda:
12:00 – 12:10 p.m., ET – Welcome/Introductions
12:10 – 12:55 p.m., ET – Presentation and Q&A
12:55 – 1:00 p.m., ET – Summary and Closure
Learning Objectives:
1. Know how to prepare for FDA inspection
2. Understand BIMO metrics & observational data
3. Know how to respond to an FDA-483
Registration Information:
Click here to register.
- Chapter Member: $0
- ACRP Member: $15
- Non-Member: $30
Contact Hour Information:
This event will offer 1 contact hour. Click here to purchase your contact hour. Please purchase and claim your contact hour by 12/19/24.
- 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.