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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): 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.

Central Virginia SOCRA Chapter Co-chairs:

1. Shirley Helm, MS, CCRP: 804-628-2942, shirley.helm@vcuhealth.org
2. Patti Feldt, AAS, CCRP 804-628-1902,  pafeldt@vcu.edu