Environmental Monitoring Investigations
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.
To date, Carl has now
garnered over two decades’ worth of extensive hands-on expertise.
Currently, he is the Chief Consultant of his very own consultant
business called aseptic-process.net, where he specializes in the aseptic
processing of pharmaceutical products in the pharmaceutical
manufacturing sector. Recently, he is in the process of creating
webinars so he can share pertinent information about pharmaceutical
manufacturing from a microbiological perspective.
Carl holds various degrees and certifications, including an M.S. in
Biomedical Quality Systems from San Diego State University, a B.S. in
Microbiology from the University of Texas, and Specialized Certificates
in QA/QC & Biotechnology from UCSD.
This seminar will provide an overview of environmental monitoring investigations and tools to complete an investigation. Environmental monitoring is the method by which cleanrooms are known to maintain a certain level of cleanliness. The methods by which cleanrooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This seminar will provide aspects to investigate and determine a root cause, as well as, appropriate actions to complete the report.
- Provide background information on regulatory guidance on environmental monitoring
- 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
Course Level - Intermediate
Who Should Attend
- Quality Assurance
- Quality Control