Effective Contamination Control and Environmental Monitoring Program

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.

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

FDB2818

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.

membership
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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance