Part 3: Operational Excellence

Overview

Hot Topics in Environmental Control & HVAC for Life Sciences

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Be able to explain the role of HVAC to control environments and protect products.
Understand the sources of global cGMP expectations.
Develop and understand applicable cGMPs for Aseptic Process vs Aseptic Technique.
Discuss HVAC system-critical parameters that must be controlled and monitored.
Distinguish among cleanroom air classifications and understand how they are applied.
Understand basic contamination and cross-contamination controls.
Understand basic HVAC theory, application, monitoring, testing, and repair.

This three-part webinar series focuses on understanding how use HVAC and facility design tools to assure environmental control and meet cGMP expectations. The class will explore critical issues at each stage of the facility lifecycle, from design through CQV and operation, such as: controlling cross-contamination between products, determining the correct classification of spaces, proper control of storage temperature and humidity, setting acceptance criteria for HVAC systems and using risk assessment to set environmental criteria. The course will address common issues and problems in the operation of a facility and maintaining a state of control.