This webinar will provide an overview of environmental monitoring and provide aspects of contamination control. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness.
The methods by which clean rooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This webinar will provide different avenues of approach to determine the source of contamination and how to deal with the contamination once the source is discovered.
Learning Objectives:
Provide background information on ISO room classifications
Provide background information on environmental monitoring methods for viable and non-viable testing
Correlate non-viable and viable results with the appropriate environmental monitoring controls
Provide possible sources of contamination and possible corrective actions
Provide possible preventative actions in order to prevent future contamination
Provide case studies on contamination events
Why Should You Attend:
Contamination issues lead to lengthy investigations and costly recalls. In recent years there have been a number of FDA actions related to contamination issues. Even the largest pharmaceutical multinationals are not immune, as evidenced by recent recalls of drug products.
Ensuring the control of contamination within your facility is paramount to the survival of your organization. Creating an effective Contamination Control program is a key to minimizing these problems and ensuring that your company does not end up as the next TV or newspaper headline.
This webinar will discuss various sources of contamination including aseptic processing, clean room classifications and alert/action limits. It will also provide an overview of an effective Environmental Monitoring (EM) program.
Topics
International regulations (ISO)
Federal regulation (FDA, USP)
Contamination events
Non-viable testing
Viable testing
Use of disinfectants for cleanrooms
Possible root causes
Identification of microorganisms
Instructor
Carl Patterson, M.S. has completed twelve 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 has helped to insure the expectations, related to aseptic processing, have been met.