Central Virginia
Central Virginia SOCRA Chapter Meeting
Title: "Demystifying FDA Part 11 Regulations and Preparing Institutions for Compliance"
Date: Wednesday, June 17th, 2020
Time: 11:30am - 12:30pm
Location: ZOOM Remote Meeting (only)
RSVP: Chapter meeting access (required):
Control+Click: SOCRA Chapter Meeting. Then, complete RSVP Form.
Zoom meeting information will be sent directly to you (email) following completion of form.
Please Note: You must attend the entire session to receive a certificate of attendance
Speaker: James Riddle, MCSE, CIP, CPIA, CRQM
VP Institutional Services
Advarra
(Note: permission has been granted by Forte/Advarra to share this session at our SOCRA Chapter meeting. This session was previously presented at the Virtual Onsemble Conference in May 2020)
Objectives:
- Address common misconceptions about Part 11
- Cover how to practically prepared for an FDA Part 11 inspection
- Discuss increasing understanding of regulations so that institutions can have a better appreciation of the regulatory landscape and help design programs accordingly
For questions, please contact Patti Feldt or Shirley Helm (Central VA Chapter co-chairs see below)
CE: 1.0 CE credit hour for SOCRA CCRP Renewal. Only SOCRA members receive Certificates of Attendance. The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
Shirley Helm, MS, CCRP Patti Feldt, AAS, CCRP
804-628-2942 804-628-1902
Shirley.helm@vcuhealth.org pafeldt@vcu.edu