Importance Of Environmental Monitoring In A Contamination Controlling Plan

Erika L. Roberts, M.F.S

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Containing and detecting microbial contamination in an engineering controlled aseptic environments is of utmost importance to current biotechnology Federal and international regulatory bodies. Having an effective environmental monitoring program is an essential tool for assessing aseptic drug product manufacturing and support. Controlled environments rely on a robust monitoring program to ensure aseptic conditions are maintained to federal and regulatory standards. By having a quality Environmental Monitoring program, manufacturers of drug products and laboratory personnel can be aware of any microbial contamination issues before they proliferate into the final product. This training will discuss the different types of Environmental Monitoring used currently in the biotechnology industry as well discussing the components of a controlled environment.

Course Objective

  • To identify which facilities and personnel that are impacted by an environmental monitoring program
  • Become familiar with the different types of environmental monitoring and controlled environments
  • Identify and become familiar with standard training practices employed to become compliant with aseptic processing monitoring
  • Implementing and maintaining a Quality environment (QA recommendations)
  • Common organisms found within the controlled environments
  • Familiarization with validation activities necessary for qualifications

Course Outline

  • Types and examples of controlled environments and the monitoring used to evaluate aseptic conditions
  • Classifications and examples of monitoring used
  • Personnel trainings and evaluation recommendations 
  • QA program for controlled environments and environmental monitoring performed/evaluations
  • Areas for validation activities and applicable regulations
  • Common errors and microbial contamination found in the aseptic environment and what to do

Target Audience

  • Biotechnology manufacturing personnel and support staff in the biotechnology/pharmaceutical technology industries
  • Quality Assurance personnel and support staff in the biotechnology/pharmaceutical technology industries
  • Quality Control laboratory personnel and support staff in the biotechnology/pharmaceutical technology industries
  • Environmental Monitoring Program manager and support staff in the biotechnology/pharmaceutical technology industries
  • Pharmaceutical and general contract laboratory companies/entities with cleanroom facilities
  • General laboratory personnel and staff who do routine work in cleanroom or control testing environment
  • Any pharmaceutical, biotechnology, general contracting and start up laboratory facilities, entities and personnel who work in controlled cleanroom or aseptic processing environments. 

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Training CD-USB

Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment

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Recorded video

Recorded video session

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Speaker: Erika L. Roberts, M.F.S,

Erika L. Roberts, M.F.S, is a Masters in Forensic Science (with an emphasis in document examination) and currently works as a Senior Quality Assurance Analyst and as a freelance consultant for the pharmaceutical/biotech industries. Having over more than a decade of experience working in many different areas of the pharmaceutical and biotech manufacturing quality environments, Ms. Roberts is uniquely qualified as a subject matter expert for sterility testing and microbial identification trainings. Her extensive background in USP regulations and applications allows for a broad perspective and a depth of training not commonly found in the industry. In addition to her microbiological work, Ms. Roberts is also a qualified trainer for document reviews of several analytical chemistry analyses commonly used in many FDA regulatory laboratories.

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