FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Requirements

Description

The FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Requirements is a webinar that covers topics such as:

  • FDA definitions of source data and types of electronic source data systems
  • FDA definitions for data elements
  • The requirements for electronic data-origination, authorization, signatures and data tracking
  • The requirement for original source data to support every data element
  • Preventing non compliance by sponsor due diligence at investigator site
  • What types of electronic data elements pose noncompliance challenges

The FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Requirements is intended for:

  • Medical Record Personnel
  • Clinical Research Coordinators and Investigators
  • Clinical Program Managers
  • Clinical CRA Monitors
  • Clinical Quality Assurance Auditors

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Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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