Developing an Environmental Monitoring Strategy for a Non-Sterile and Aseptic Processing Area (Controlled/Classified Environment) -- To Include HVAC and Utility Systems 2015 is a course that covers topics such as:
- How identify the key elements
- 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
Developing an Environmental Monitoring Strategy for a Non-Sterile and Aseptic Processing Area (Controlled/Classified Environment) -- To Include HVAC and Utility Systems 2015 brings together:
- Regulatory professionals
- Quality professionals
- Manufacturing engineers
- Compliance professionals
- Quality auditors
- Quality engineers
- Microbiology
- Quality Control
- Document control specialists