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Creating an Effective Contamination Control & Environmental Monitoring Program

Duration : 60 Minutes

Carl Patterson, MS, SSGB, SSBB,

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 Read more

This seminar 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 seminar will provide different avenues of approach to determine the source of contamination and how to deal with the contamination once the source is discovered.

Course 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.

Course Outline:

• 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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

This webinar will provide valuable assistance to all professionals in following functional areas:

• Quality Assurance Personnel
• Logistics
• Manufacturing
• Quality system auditors
• QA directors and managers
• Microbiology analysts and technicians
• Consultants
• Validation Personnel
• Quality Control Personnel
• Microbiology Professionals
• Warehouse Managers
• Facilities/Maintenance
• Regulatory and Compliance Management

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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