This Live Online Training will present the basic methodology of evaluating the Environmental Monitoring (EM) data using elementary Statistical Process Control (SPC) tools as well as empirical approaches to set microbial control limits for clean rooms. This course will address the following issues:

– Overview of controlled rooms classifications, elements of an EM program and present EU and FDA regulations including the recent ISO 14664 changes.
– How to organize and present an abundant amount of microbial data in meaningful graphs
– To understand how action and alert control limits are set
– How to demonstrate that the environmental microbial monitoring process is under a state of control
– How to calculate and plot the newly proposed Contamination Recovery Rates in USP Chapter <1116>
– To detect a trend in the environmental microbial monitoring process
– How to apply risk assessment in investigations

All above issues will be demonstrated on examples and case studies of microbial counts generated in controlled rooms of manufacturing facilities of sterile products.

A prior knowledge of control charts is an advantage.