Developing an Environmental Monitoring Strategy for a Non-Sterile and Aseptic Processing Area (Controlled/Classified Environment) -- To Include HVAC and Utility Systems 2015

Topics

• 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

Who should Attend

• Regulatory professionals
• Quality professionals
• Manufacturing engineers
• Compliance professionals
• Quality auditors
• Quality engineers
• Microbiology
• Quality Control
• Document control specialists