Parenteral Drug Association (PDA)

Parenteral Drug Association (PDA)

Fundamentals Of An Environmental Monitoring Program

This course will identify microbiological and particulate control concepts and principles as they relate to the manufacture of pharmaceutical products, and other designated controlled environments. The course will discuss, in detail, controlled environmental test methods, with a focus is microbiological control. The most stringent concepts of environmental monitoring as it relates to facility control and compliance are presented for sterile product manufacturing, but these concepts can also be used as an aid to design a program for non-sterile product manufacture.

Environmental surveillance is a tool utilized to evaluate the effect of controls on the manufacturing environment. A process to assess the clean room and other controlled environments of a pharmaceutical facility can serve as an adjunct to the sterility assurance program for the microbial quality of drugs. The items addressed in this course include definitions, standards, surveillance support systems, system surveillance, validation systems, definitions and typical frequencies and levels.

Who Should Attend

  • Quality Control/Quality Assurance - Technicians, Microbiologists, Specialists, Managers and Supervisors
  • Validation/Engineering - Technicians, Specialists, Managers and Supervisors
  • Manufacturing - Specialists, Managers and Supervisors

Upon completion of this course, you will be able to:

  • Apply current regulatory guidance to your environmental monitoring program
  • Implement improved environmental monitoring procedures
  • Compare and contrast new and existing environmental monitoring equipment.
  • Outline how to best utilize current environmental monitoring definitions
  • Define key environmental monitoring concepts

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