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Boston Professional Events List
Live Webinar Risk Based Environmental Monitoring
Link to Website
Ticket Price: $179 One Dial-in One Attendee | Corporate Live Recorded $279 One Dial In - Max 10 attendees |Group $695 Multiple locations upto 5 dial in | Recorded $249
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.
Key Learning Objectives of your Topic:
• 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
Who will Benefit
• Environmental Monitoring Samplers/Managers
• Quality Assurance/Quality Control professionals
• Sterility Assurance professionals
Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy has been in the industry for 15 years serving in numerous quality management roles, such as the director of product quality, the oversight of sterility assurance practices and provided QA oversight of numerous filling and packaging operations.
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