GMP Cleanroom Routine Environmental Monitoring & 21 CFR Part 11 Data Integrity

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 21 CFR Part 11 ALCOA guidance and shows how the new MET ONE 3400+ non-viable air particle counter can automate routine environmental monitoring programs to help manage data integrity challenges.

Learning Objectives:

  • Learn about the differences between Cleanroom Routine Environmental Monitoring and Cleanroom Classification
  • Explore the manual steps of Cleanroom Environmental Monitoring that can lead to human error and data integrity issues
  • Understand how automating Cleanroom Environmental Monitoring SOPs can help reduce human errors and improve data integrity