Course Description:
This course is based on the WHO Guideline on Data Integrity and provides comprehensive guidance on maintaining data integrity in pharmaceutical laboratories. Participants will learn the definition of data integrity and related terminology, explore different types of data and records, and understand the requirement of data and records to be attributable, legible, contemporaneous, original, and accurate, complete, consistent, ensuring and available (ALCOA+ principle) throughout the data lifecycle. The course also covers compliance requirements, common data integrity issues (e.g., fraud, error, manipulation), and strategies for prevention of potential and remediation of identified data integrity issues.
Through practical examples and discussions, participants will gain the knowledge needed to implement ALCOA+ principles, identify gaps in current practices, and develop robust procedures to support data integrity across laboratory operations.
Pricing varies. Please inquire for more info at https://go.usp.org/Services.
Upon completion of this course, you will be able to
- Define data integrity and related terms
- Implement the principles of ALCOA+
- Identify various types of data and records
- Explain the stages of the data integrity lifecycle
- Recognize key elements of data integrity compliance
- Identify common errors and gaps in laboratory data integrity and determine appropriate corrective actions
- Develop and document proper procedures to support data integrity
Who should participate:
- National regulatory authorities
- National control laboratories
- Private QC laboratories
- QC lab in manufacturer