Ensuring Compliance with Part 11: A Site’s Perspective
Program Agenda: 5:00 pm ET – Webinar Replay
Registration Cost:
- $2 for Chapter Members
- $5 ACRP Members
- $7 Non-Members
Program Description: Investigative sites are navigating increased clinical trial complexity and administrative burden. To improve efficiencies, more and more sites are managing research documentation and processes electronically. Despite this increasing trend, many sites do not understand how to ensure compliance with the regulatory requirements for electronic records and signatures, or 21 CFR 11 (Part 11).
While sites are responsible for understanding and following these regulations, it can seem overwhelming for a site with limited technical resources.
Join us for an educational presentation to learn what clinical research sites should know about Part 11 compliance. After attending this webinar, you’ll understand key critical components of how to implement and maintain an effective compliance process. Attendees will also receive a Vendor Selection / Audit SOP.
Upon completion of this Webinar replay, attendees should be able to:
- Understand who must comply with 21 CFR 11
- Identify critical components related to 21 CFR 11 compliance
- Understand steps for implementing and maintaining an effective compliance process
Having monitored more than 300 clinical trials, Cristina Ferrazzano Yaussy is a certified clinical research professional with an array of experience in both industry and academic settings. She obtained a MPH from Case Western Reserve University, has led hundreds of educational presentations both locally and nationally, and has been awarded first honors by several professional research organizations for her work in research compliance and oversight.
Social Media Handles (Facebook, Twitter, LinkedIn, etc.):
Contact Hour Cost:
- FREE for Chapter Members
- $15 ACRP Members
- $30 Non-Members
Refund Policy: Refunds will only be processed if the event is canceled by the chapter
Level: All audiences