PERFORMING ANALYSIS IN A REGULATED OR ACCREDITED LABORATORY
Working in a regulated or accredited laboratory is quite different to working in other laboratory environments, and is essentially about:
Producing results that are accurate, precise, reliable and trustworthy
Identifying factors that could compromise the accuracy, precision, reliability and trustworthiness of analytical test results, and establishing appropriate controls
Establishing and following standard operating procedures and test methods
Documenting that the correct procedures and methods have been followed and creating a paper trail that provides documented evidence which can testify to the accuracy, precision, reliability and trustworthiness of the scientific data which has been produced
This course will discuss the procedures and practices needed to be followed when performing analysis in such a laboratory. In particular we look at some of the most important topics in current Good Laboratory Practice, for laboratory staff, that is, how to carry out and document your laboratory work in a compliant manner.
The checks and controls that should employed
How work should be documented
How the results should ensure be traceable to recognised standards, and
How it can be assured that analysis correctly was performed and how the accuracy, precision, reliability and trustworthiness of results can be assured
This course concludes with an assessment for which a certificate is issued upon successful completion which meets Pharmaceutical EU / PIC/S GMP requirements.