Developing an Environmental Monitoring Strategy for a Non-Sterile and Aseptic Processing Area (Controlled/Classified Environment) -- To Include HVAC and Utility Systems 2015
The fundamentals of an environmental monitoring program
The various inspection approaches to monitoring a "Controlled" and "Classified" environment
How the regulations impact their cGMP non-sterile or aseptic processing areas and their "Controlled" and "Classified" environment
Develop and initiate the use of a purified water, WFI and steam system
How to determine the regulatory requirements required for an environmental monitoring program
How to use Failure Mode Effects Analyses to determine the critical sampling locations, appropriate sampling methodologies and frequencies for both environmental and utility systems
The issues of their water system before the system is commissioned
How to determine appropriate Alert and Action Levels for different ISO and water classifications
How to develop DQ/IQ/OQ/PQ requirements
The movement from a "paper" method of data trending
Who should Attend
Regulatory professionals
Quality professionals
Manufacturing engineers
Compliance professionals
Quality auditors
Quality engineers
Microbiology
Quality Control
Document control specialists
Past Events
Developing an Environmental Monitoring Strategy for a Non-Sterile and Aseptic Processing Area (Controlled/Classified Environment) -- To Include HVAC and Utility Systems 2015 - 05-06 Oct 2015, Grand Hyatt San Francisco, California, United States (53600)
Developing an Environmental Monitoring Strategy for a Non-Sterile and Aseptic Processing Area (Controlled/Classified Environment) -- To Include HVAC and Utility Systems 2026
Important
Please, check "Developing an Environmental Monitoring Strategy for a Non-Sterile and Aseptic Processing Area (Controlled/Classified Environment) -- To Include HVAC and Utility Systems" official website for possible changes, before making any traveling arrangements
