Focusing on regulations, guidance, and current trends of environmental monitoring plans, join David Vincent in this webinar, where he will give you an in-depth look at cleanroom design and environmental monitoring, trending EM data, and key components of EM summary reports. Part 1 – Regulations, Guidance and Current Trends Cleanroom design engineering vs. regulatory Personnel control and monitoring Cleanroom operation and maintenance Part 2 – Setting Up a Meaningful EM Plan Establish a compliant and manageable EM program Risk-based approach for sampling sites Points to consider when qualifying clean rooms Phenotypic, genotypic methods approach Part 3 – Choice and Evaluation of Equipment for EM Non-viable particle monitoring equipment Viable particle monitoring equipment Microbial ID systems Part 4 – Trending EM Data Using Excel and OtherElectronic Systems Interpretation of results Retrieve vital information on the condition of the facility Trend analysis and review of data Part 5 – Key Components of EM Summary Reports Rapid review of EM controls Sources of contamination Recent FDA 483 observations related to EM and data trending
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