This practical course will first 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
- How to draw useful Control Charts with this data, using the software program Minitab®17
- 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.
For more details and registration download pdf from www.gmp-compliance.org