Wednesday, August 12th, 2020

Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points per month, manual data transcription and all too frequently data gaps and data integrity challenges. This webinar discusses the difference between cleanroom classification and routine environmental monitoring, outlines the FDA 21CFR part 11 ALCOA guidance and shows how the new MET ONE 3400+ non-viable air particle counter from Beckman Coulter Life Sciences can automate routine environmental monitoring programs to help manage data integrity challenges.

Learning Objectives:

  • Why ISO 14644-1:2015 cleanroom classification sample locations should not be used for routine environmental monitoring of GMP cleanrooms
  • How the FDA 2018 updated guidance on 21CFR part 11 data integrity applies to GMP cleanroom routine environmental monitoring
  • How automating routine environmental monitoring SOPs inside the air particle counter itself to form interactive sampling maps helps to automate the process and reduce human error

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