Training Program Title

Understanding, Achieving and Maintaining 21 CFR Part 11 Compliance


Forte MarketingFollow

CTSA Hub Administered


Contact Information

Training Program Description

In order to submit captured data to the FDA, organizations must use a 21 CFR Part 11 validated system; however, the delegation of roles and responsibilities between an organization and vendor may be unclear to those new to the validation process.

Join us for this webinar to hear Forte’s Director of Product Management, Shannon Roznoski, and Product Manager, Stuart Cotter, provide an overview of 21 CFR Part 11 and discuss the roles both organizations and vendors play during the validation process. These two expert presenters will share ways organizations can work with their vendors to successfully implement a validated system and maintain a compliant status throughout each upgrade.

Competency Keywords

Clinical research, Clinical trial, FDA (Food and Drug Administration), Best practice

Other Keywords

21 CFR Part 11

Digital Commons Disciplines

Medical Education



Cost to Access


Competency Domains

Clinical Trials Operations; Study and Site Management

Learning Objectives

  1. The FDA requirements for 21 CFR Part 11
  2. Processes and controls organizations should establish prior to system implementation
  3. How to identify controls and procedures vendors should have in place, and additional considerations for hosted systems
  4. Change management considerations for maintaining a system in a validated state during an upgrade

Delivery Method


Target Learners

Principal Investigators; Clinical Research Professionals (other than PI)

Learning Level



On demand

Associated Assessment