Event Calendar

Chapter Chairperson:

Shirley L.T. Helm, MS, CCRP
Phone: 804-628-2942
Email

Patricia A. Feldt, CCRP
Phone: 804-628-1902
Email

 

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