Connecticut

SOCRA Connecticut Chapter Meeting

Date:                     Thursday, February 27, 2025 

Time:                    12:00 – 1:00 PM EST via ZOOM

Course Title:      Managing 21 CFR Part 11: How can it affect you the user

Presenter:           Jen Simpson

OnCore Product Manager

Research Informatics Office (RIO)

Yale University

Learning Objectives: By the end of this presentation, participants will be able to understand the key requirements and implications of managing a 21 CFR Part 11 compliant system, and how it may impact the end-user experience. For this SOCRA session, we will review:

• Common compliance issues.
• Key requirements needed when managing an application that is validated as 21 CFR Part 11 compliant.
• Address technical and procedural documentation and its real-world application.
• Discuss how all points tie into the end-user experience.

Cost:      Free Admission

Credit:   SOCRA Members may claim 1 CE towards SOCRA Recertification. 

Only SOCRA members will receive a certificate of attendance.

Location:             The meeting will be held remotely via ZOOM.

                              https://yale.zoom.us/j/99794575759

Please share this announcement with your colleagues.

Members and Non-members welcome!

Chapter Locations and Site Contacts

More Information: Alyssa Gateman, MPH, CCRP, Chapter Chairperson, at alyssa.gateman@yale.edu