Environmental Monitoring Investigation Techniques for Effective Contamination Control
Speaker: Carl Patterson
Speaker Designation: Director Of Quality at LATITUDE Pharmaceuticals, Inc.
Speaker: Carl Patterson
Speaker Designation: Director Of Quality at LATITUDE Pharmaceuticals, Inc.
Your environmental monitoring (EM) program must demonstrate control over both viable and non-viable particles found in critical areas of your operation.
A vigorous and stringent environmental monitoring program provides you with critical data that assists you in preventing future contaminations. It is critical to ensure compliance with the most recent standards and to drive your productivity forward, with a much lower possibility of having to stop production due to contamination.
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.
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.
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. Furthermore, 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.