On-Demand Webinar: 21 CFR Part 11: Vendor vs. Sponsor Responsibilities 

Presented by Shannon Roznoski

Webinar Details:


This webinar was originally recorded on March 16, 2016. 

Duration: 45 minutes

 

Watch Now!

Many clinical researchers are making the switch to software solutions that electronically capture data for their clinical trials. In order to submit this captured data to the FDA, sponsors must use a 21 CFR Part 11 validated system; however, the responsibilities of sponsors versus vendors during this process may be unclear to those new to validation. Join us for this webinar, as Shannon Roznoski, Product Manager at Forte Research Systems, walks through an overview of 21 CFR Part 11 and the roles both vendor and sponsor play during the validation process of an EDC system.

 

You’ll learn how to:

  • Distinguish when the regulation applies to validation activities
  • Determine processes and controls sponsors should establish prior to EDC system implementation
  • Identify controls and procedures EDC vendors should have in their systems

About the Presenters:

Shannon Roznoski

Webinar Presenter

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Shannon Roznoski is the EDC Product Manager at Forte Research Systems, responsible for the strategic planning and management of Overture EDC. Prior to joining Forte, Shannon worked for 14 years at Covance in various roles including early phase data management and project management. She earned a Bachelor of Science in Horticulture from the University of Wisconsin Madison and is a CCDM through SCDM.

Tami Haas

Webinar Host

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Tami is the Product Marketing Manager for Overture EDC at Forte. Overture is a user-friendly electronic data capture system with an elegant design and easy-to-navigate user interface, that fully supports compliance with 21 CFR Part 11.