Overview of GMP aspects for Senior Management
This eLearning module is to understand, the basics of Chromatography, including the most commonly used separation techniques, such as high performance liquid chromatography and gas chromatography, and their basic instrumentation.
Introduction to GMP
Understanding of GMP
US FDA 6 systems
Core GMP systems such as Quality System, Personnel ,Facility & equipment and Documentation
Why it matters
Handling of instruments by untrained personnel can lead to erroneous and non-reproducible results, leading to OOS/OOT and further time loss in root cause investigation.. So it is important to understand the science and theories behind chromatography techniques to avoid mistakes, and to identify the correct root cause to avoid repeat errors.
Who is it for
This module is designed for all employees in analytical quality control and analytical quality assurance, as well as in teams involved in performing and reviewing of chromatographic methods.