Data Integrity for Quality Control Laboratories

To ensure the quality of raw materials, in-process materials, and finished goods, laboratory data integrity is of great importance in current Good Manufacturing Practices (cGMP) for the US Food and Drug Administration (FDA)-regulated industry. This course focuses on data integrity in the Quality Control (QC) laboratory. Topics in this course include: History, Strategies for Control, and Ethics. After completing this course, learners will be able to recognize potential strategies for maintaining data integrity and the consequences of noncompliance, and identify the types of data integrity issues found by FDA.

After this course learners will be able to recognize the history of data integrity. identify the types of data integrity issues found by fda. recognize possible consequences of data integrity noncompliance. identify possible strategies for remediation of data integrity issues. recognize the effects of intentional and unintentional errors.