Introduction to this course: 

This course covers essential data integrity and data governance concepts, regulatory expectations, and the ALCOA+ principles. Gain the skills to manage data effectively throughout its lifecycle, ensuring accuracy, consistency, and reliability for drug and medical device safety.

Who should attend: 

This course is designed for professionals responsible for data management in regulated environments, and personnel involved in ensuring data integrity and regulatory compliance in GxP environments.

Learning outcomes: 

By the end of this lesson, you will be able to:

• Define key terms related to data integrity and data governance.

• Express the importance of data integrity and data governance by explaining the significance of ALCOA principles and how they apply to data management practices.

• Enhance data integrity throughout the data lifecycle by applying ALCOA+ principles to evaluate and improve data management processes.

What will I gain: 

Participants will gain a comprehensive understanding of data integrity and data governance in GxP environments, and acquire practical skills in implementing ALCOA+ principles to ensure regulatory compliance and safeguard data quality, integrity, and reliability throughout its lifecycle.

Prerequisites: 

Prerequisites for this course include a basic understanding of GxP regulations and familiarity with quality management systems in the life sciences industry. Basic knowledge of data management practices and regulatory compliance standards is recommended.

Additional information: 

Course duration: 00:37:17

Course code/version (effective date): L-31/v1.0 (26/04/2023)