The importance of designing an effective Environmental Monitoring (EM) program cannot be overemphasized. The data from this program provides an effective measuring tool that determines an effective cleanroom control from a Facility design, validation, implementation, disinfection, disinfectant effectiveness, gowning controls, cleanroom trafficking, aseptic controls, personnel training, and practices. It also serves as a critical program that supports and guides other contamination control key evaluators and other production and testing processes that help in ruling out cleanroom contamination using the data generated.
This accredited training will discuss the various steps associated with the EM program from the Phases, through Validation, Implementation, Procedural Steps, Documentation Practices, Data Management, Trending of Data, EM Excursion, and the relationship of the cleanroom state of control and product impact and analysis per 21 CFR Parts 211.113 “Control of Microbiological Contamination” and 21 CFR Subpart G Section 820.70.
Upon completion of this course, you will be able to:
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This 90-minute ON DEMAND training will provide a great resource to product manufacturers with personnel in the Pharmaceutical, Biotechnology, Biologics, Drugs, Diagnostics, Cell Therapy, Medical Device, In-vitro Diagnostics industries within the following functions:
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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