Facility Qualification – Cleanroom Design and Environmental Monitoring

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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