Environmental Monitoring is a tool utilized to evaluate the effectiveness of the contamination control strategy in the aseptic and surrounding manufacturing environment. Equipment and tools to assess the clean room and other controlled environments of a pharmaceutical facility serves, in parallel, to the sterility assurance program for the microbial quality of drug products and drug substances. The ideology addressed in this training course include regulations, current methodologies, equipment, identification, disinfection and cleaning, monitoring frequency and alert/action levels.
This training course will include interactive discussion on current methods, best practices, and rapid methods. It will focus on utilizing monitoring to identify gaps in the contamination control strategy in order to improve the quality of the aseptic environment, support investigations and satisfy the global regulatory expectations from a risk-based viewpoint.
Participants will also receive a free copy of PDA Technical Report No. 13: Fundamentals of an Environmental Monitoring Program.