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

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

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

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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