GMP Environmental Monitoring 2022 - Environmental Monitoring Investigation Techniques for Effective Contamination Control

Environmental Monitoring Investigation Techniques for Effective Contamination Control
Presenter : Carl Patterson
Scheduled On : January 13 2022 1:00 pm
US/Canada (Eastern Time - ET)
Duration : 60 Minutes
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.
Why You Should 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.
Learning Objectives:
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
Areas Covered in the Session :
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
Who Should Attend:
Quality Assurance Departments
Quality Control Departments
Research and Development Departments
Regulatory Affairs Departments
Manufacturing Departments
Compliance Departments
Microbiology Professionals
Warehouse Managers
Validation Departments
Facilities / Maintenance Professionals
Quality System Auditors
Abount the Speaker :
Carl Patterson
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.