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Root Cause- Is/ Is Not Tool



Risk Based Environmental Monitoring


DATE:  December 10, 2019

TIME: 10 am Pacific, 1 pm Eastern

PRESENTER: Danielle DeLucy


Environmental Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a risk-based approach. The use of sampling data for the identification and mitigation of risk becomes a critical element in this process. No longer is it enough to utilize data for reactive excursion reporting.

This presentation will discuss how to establish a risk-based Environmental Monitoring Program.  During this session we will discuss how to set up a new Environmental Monitoring Program based on risk as well as how to perform a reassessment of your current Environmental Monitoring Program to re-establish sampling locations and frequencies based on results of your risk assessments coupled with the knowledge gained from your current EM Program historical data. 


This webinar will discuss:


  • Current regulatory requirements for environmental monitoring
  • How to select sample locations based on risk
  • How to perform a risk assessment to support your EM Program
  • Differences in room classifications and impact to your EM Program
  • Monitoring methods, equipment and media types
  • Data collection, microbial identifications and data trending options


Choose to attend only the Live presentation, or order the On-Demand recording to watch at your convenience!

All On-Demand Webinars are viewed through ePath, the PathWise online learning management system.

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