Free on-demand webinar: Facility Qualification – Cleanroom Design & Environmental Monitoring

This free webinar from KENX focuses on regulations, guidance, and current trends of environmental monitoring plans

KENX invites you to download a complimentary on-demand webinar: Facility Qualification – Cleanroom Design & 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.

REGISTER HERE: https://bit.ly/2srltK0

 

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

This is just one example of the rich content you will receive at Cleanroom Validation, Disinfection, and Environmental Monitoring conference this February 17 – 19, 2020 in San Diego, CA. Find out more on the KENX website: www.kenx.org.

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