This training course will review routine environmental monitoring (EM) program requirements, EM program qualification requirements, use of risk tools for determination of microbial contamination sources in production environments and processes, and EM risk assessment tools and instruction on how to perform them.
Limited information and guidance currently exist on how to conduct EM risk assessments. Current regulatory requirements prescribe that sample site locations and sampling frequencies must be risk-based with documented rationales, but there is little to no guidance on how to perform these types of risk assessments. There is currently large interest in the industry for guidance on this topic.
This training course will present information on the establishment of a risk-based EM program. It will cover both the establishment of new as well as reassessment of current EM programs to bring them into compliance with industry standards. Routine EM program requirements and EM program qualification requirements will also be reviewed. Instruction will be given on the use of risk tools for determination of microbial contamination sources in production environments and processes, and on the use of EM risk assessment tools.
There will be small group breakouts for completion of EM risk assessments: Fishbone Diagrams, FMEAs and HACCPs. The goal of this training course is to understand the tools available for conducting EM risk assessments and how to properly utilize them to create risk-based EM programs.