Laboratory Investigations – Handling Out of Specification, Atypical and Suspect Test results, and Deviations from Established Laboratory Procedures
The electronic learning course, which is part of the Good Laboratory Practice program, discusses the activities that should be carried when out of specification, unexpected and suspect results are obtained, or an event occurs which causes a deviation from established laboratory procedures, during laboratory testing. These have to be handled in an appropriate manner which normally includes a documented investigation and appropriate follow up actions which should be documented and approved.
Specifically this course consists of the following modules
The Barr decision
How to perform an investigation
This course concludes with an assessment for which a certificate is issued upon successful completion which meets Pharmaceutical EU / PIC/S GMP requirements.