Importance Of Environmental Monitoring In A Contamination Controlling Plan
Duration : 60 Minutes
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 Read more
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
Course Objectives:
• 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
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
