Facility Qualification – Cleanroom Design and Environmental Monitoring

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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

Click Here to Register




David Vincent, MPH, PhD

CEO, VTI Life Sciences

Mr. Vincent has over 33 years’ experience in the health care industry specializing in the, biologic, biotechnology and biopharmaceutical industries and has over 25 years dedicated to the field of validation. Mr. Vincent has provided both project management and project execution for numerous clients national and international. He is responsible for managing and supporting many different product launches. He teaches at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776.