Topic outline

  • Data Integrity

    3 courses covering Data Integrity: Overview and documentation completion, review and approval.  Data Integrity: Beyond the basics.  Data Integrity: Management requirements.
    Course Code TEC-177
    Region

    UK and Internationally
    Delivery  e-Learning
    Role Role: All-roles
    Competence Technical
    Sector Sector: Pharmaceuticals

    This Course is Aimed at
    This eLearning course is aimed at anyone working in the Pharmaceutical Industry.


    Programme Content and Key Areas

    Data Integrity: Overview and Documentation Completion, Review and Approval

    Course 1 of our Data Integrity Series

    Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements.  This eLearning course is aimed at anyone working in the Pharmaceutical Industry and is designed to provide an overview of what is meant by data integrity, what needs to be considered during documentation completion, review and approval and how to keep your data complete, consistent and accurate throughout the data lifecycle.

    Data Integrity: Beyond the Basics

    This course (course 2) will build on the key messages of course 1 and go beyond the basics.  It will look at some more specialised or particular aspects of this topic which has such wide ranging impact.  This course consolidates knowledge and experience of 11 years work from an ex MHRA Inspector.  Management and the Quality Unit need to have a deeper understanding of Data Integrity to give them the confidence to get involved and this module is designed to highlight the known weaknesses in company systems.  

    Data Integrity: Management Requirements

    Data Integrity course 1, Basics of Data Integrity addressed what everyone needs to know for this essential topic.  Course 2 went beyond the basics focusing on the technical details for subjects such as auditing and computer systems management. In this third course we build on your essential knowledge to understand what the Senior Management should ensure is in place, in use and effective.


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