Environmental Monitoring – Knowing your cleanroom

Overview:

This webinar will provide the proper methods and techniques required to maintain a clean room per FDA and ISO regulations. By the use of viable and non-viable testing, a cleanroom can be maintained. The results collected can determine the state of control the cleanroom operates on a continuous basis.

Why Should You Attend:

Personnel involved with monitoring, trending, and drawing conclusions from the testing related to environmental monitoring. Personnel who are uncertain their current environmental monitoring program is effective and/or meets current FDA and ISO regulations. Personnel who need to understand what controls are in place in order to maintain a state of control to their cleanroom(s).

Areas Covered in this Webinar:

Environmental monitoring is the process of testing cleanrooms to ensure these rooms maintain a state of control. Non-viable testing is testing done to monitor the amount of total particulates within a cleanroom. Viable testing is categorized into air and surface monitoring. The viable air monitoring can be further divided into passive monitoring and active monitoring. Cleaning agents are used to lower the amount of viables within a room and increased usage can be done during contamination events.

Learning Objectives:

The most appropriate cleaning agents and possible schedules for use of the cleaning agents

Trending methods in order to ensure the cleanroom is maintaining a state of control

How a cleanroom can be maintained to perform in accordance with ISO and FDA regulations

Who Will Benefit:

Pharmaceutical Manufacturing Companies

Contract Manufacturing Companies (CMOs)

Personnel involved with Environmental Monitoring Operations

Speaker Profile:

Carl Patterson, M.S. has completed twelve (13) plus years in the biotechnology, pharmaceutical manufacturing, and quality fields. He completed his Bachelor’s of Science in Microbiology from the University of Texas.  

Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master’s of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and environmental monitoring. He has helped to insure the expectations, related to aseptic processing and environmental monitoring, have been met.

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