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  • New Part 11 Guidance for Clinical Trials: What This Means
    for You

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Friday - Jul 05, 2013 10:00 AM
  • End Time:
  • Friday - Jul 05, 2013 11:00 AM
  • Location:
  • Online
  • This training on 21 CFR Part 11 guidance for clinical trials will explain the new 21 CFR Part 11 regulations for electronic records and what that means for your organization and the clincial studies you conduct.

    Why Should You Attend:

    FDA regulations related to Good Clinical Practices includes Electronic Records and Electronic Signatures. Governing those is 21 CFR Part II. The Department of Health and Human Service equivalent to this regulation is 45 CFR 142 Security and Electronic Signature Standards and 45 CFR 160 and 162 Health Insurance Reform: Standards for Electronic Transactions.

    This 60-minute webinar will help you to be aware of these regulations and what that means for your organization and study. For instance, you wish to scan your case report forms and keep them in an electronic format. Is this acceptable? A research participant wishes to email back his signed consent form. Is this acceptable? Are you set up to receive such documents? Information provided in this webinar will help answer these questions and more, and help you work through other complex scenarios that may arise.
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