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How to Comply with 21 CFR 11 Requirements for Electronic Medical Records - Webinar

  • ID: 4539889
  • Webinar
  • June 2018
  • Region: Global
  • 90 Minutes
  • NetZealous LLC
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The principles outlined in this webinar can be used for computerized systems that contain any data that are relied on by an applicant in support of a marketing application, including computerized laboratory information management systems that capture analytical results of tests conducted during a clinical trial. For example, the recommendations in this webinar would apply to computerized systems that create source documents (electronic records) that satisfy the requirements in 21 CFR 312.62(b) and 812.140(b), such as case histories.

This webinar also applies to recorded source data transmitted from automated instruments directly to a computerized system (e.g., data from a chemistry autoanalyser or a Holter monitor to a laboratory information system). This webinar also applies when source documentation is created in hardcopy and later entered into a computerized system, recorded by direct entry into a computerized system, or automatically recorded by a computerized system (e.g., an ECG reading). The webinar does not apply to computerized medical devices that generate such data and that are otherwise regulated by FDA.

Areas Covered in the Session:

What are source documents and why are they important? (FDA and ICH GCP E6 Guideline)
What are required characteristics for source documents?
What is 21 CFR Part 11?
How can you apply 21 CFR 11 and ICH E6 to source documents?
How EMR Data is used in Clinical investigations
How to plan electronic source document deficiencies
How to Manage site and sponsor interactions with regards to EMR
What are future expectations for EMRs (FDA Draft Guidance) and the impact on sponsors and sites
Note: Product cover images may vary from those shown
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  • Investigators
  • Clinical Research Coordinators
  • Device and Drug Study Clinical Research Associates
  • Clinical Research Associate Managers
  • Project Managers
  • Quality Assurance Personnel
  • Regulatory Affairs Personnel
  • Doctors and Nurses involved in Clinical Trials including Monitors, Clinical Research Associates and Clinical Research Co-ordinators
  • Regulators dealing with FDA-Regulated Clinical Investigations
Note: Product cover images may vary from those shown