On-Demand Webinar

Regulatory Fine Points: Exploring 21 CFR Part 11 Validation

FDA is placing an increased emphasis on compliance with 21 CFR Part 11. Institutions, health systems, IRB offices, private research clinics, and developers—to name a few—need to understand the basics of the regulation and how to comply.

In this session, James Riddle, Stuart Cotter, and Shannon Roznoski of Advarra will review how the partnerships between software vendors, research institutions, and other stakeholders work to support regulatory guidelines. They will discuss in detail which parts each party is responsible for when building, implementing, and maintaining clinical trials software in a government-regulated process.

Learning Objectives:

  • Understand basic requirements of 21 CFR Part 11 as it relates to computer systems commonly used by research institutions
  • Identify which systems at your institution may be subject to Part 11
  • Determine the basic actions, policies, and procedures that need to be taken to validate computer systems at your institution

Presented By

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James Riddle


VP of Research Services & Strategic Consulting

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Stuart Cotter

Director of Product Management

Shannon Roznoski.png

Shannon Roznoski

Director of Product Management

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Who should watch?

This content applies to operational staff responsible for enterprise technology, as well as roles related to regulatory and data management such as Regulatory Manager, Regulatory Coordinator, Data Manager, and CRA

CE Credits

Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations. This session meets the Certified IRB Professional (CIP) recertification guidelines for a maximum of 1 credit.

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.

Certificate of Attendance

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.

DATE: July 8, 2020
Time: 1 pm ET | 10 am PT
Duration: 1 hour

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