In collaboration with Bioanalysis Zone and the Society of Quality Assurance’s Bioanalytical Specialty Section (SQA-BASS), the following questions were submitted to BASS this quarter for comment.
Question 1: How and to what extent should Quality Assurance (QA) professionals (e.g., QA managers) be involved in the training process for personnel and the training strategy of bioanalytical labs? What type of general documentation would they need for this?
Proper training is the cornerstone of success for any professional working in a regulated laboratory environment. According to the US FDA Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) regulation 21 CFR 58.31 (f), Testing Facility Management is responsible for assuring that personnel clearly understand the functions they are to perform .
In many companies, QA is responsible for providing GLP training and/or ensuring that it occurs.