Author
Walid El Azab
Attendees:
This workshop is designed for professionals responsible for designing, executing, and maintaining environmental monitoring programs in controlled manufacturing environments. Key attendees include Microbiology Specialists, Environmental Monitoring (EM) Program Managers, Quality Assurance and Quality Control personnel in sterile operations, Contamination Control Strategy (CCS) leads, and Facility & Process Engineers involved in cleanroom design.
Abstract:
This hands-on, one-day workshop tackles the common industry challenge of developing an Environmental Monitoring Risk Assessment (EMRA) that is both scientifically robust and practically executable. Moving beyond theoretical guidelines, the session provides a structured, step-by-step methodology for assessing contamination risk by integrating critical factors such as facility layout, process design, product criticality, and personnel flows. Through interactive exercises, participants will learn how to translate their risk assessment into the cornerstone of a defendable monitoring program—defining scientifically justified sampling locations, frequencies, and types. The workshop further covers how to qualify the program's effectiveness (EMPQ), set meaningful control limits, and leverage data trending and dashboards for proactive management. By the conclusion, attendees will leave equipped with practical tools, templates, and a clear action plan to implement or refine an EMRA that serves as a dynamic, living document, directly enhancing contamination control, operational excellence, and regulatory preparedness.
Learning Objectives:
Upon completion, participants will be able to:
- Apply a structured methodology to conduct a facility- and process-specific Environmental Monitoring Risk Assessment (EMRA).
- Utilize the EMRA to scientifically justify and define key elements of an EM program, including monitoring locations, frequencies, and sampling methods (viable/non-viable).
- Develop a strategy for qualifying the EM program (EMPQ) and establish statistically sound alert and action limits.
- Perform meaningful trend analysis on historical EM data to enable proactive contamination control and support continuous improvement initiatives.
- Transform the EMRA from a static document into a foundational, living tool that actively supports the site's contamination control strategy and regulatory compliance.
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