Good Documentation Practice (GDocP) & Essential Documents

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This professionally developed Good Documentation Practice (GDocP) and Essential Documents course explores data integrity and document requirements in detail and demonstrates how GDocP can be implemented into a number of roles.

Good Documentation Practice is mandatory to ensure that documentation (and ultimately products) meet industry standards and other legal responsibilities in the pharmaceutical sector.


Learning Objectives

  • To understand what GDocP is and why it is important
  • To understand the various types of essential documents
  • To explore which essential documents are required at which stage of the clinical trial process
  • To examine ICH GCP E6 R2 and its requirements regarding essential documents and how to archive essential documents according to ICH GCP standards
  • To know about different types of documents
  • To understand different types of data
  • To understand the importance of data integrity and ALCOA+ and be able to implement these in your role
  • To understand the role of security and data protection in GDocP


Course Support

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