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Microbiological and Business Risk of not Testing Raw Materials for Microbial Presence

4323
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 webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.

Course Objectives:

Raw materials are often the major source of microbial contamination that is introduced into the manufacturing process. Raw materials of natural origin, such as animal and plant source, support an extensive and varied micro flora. Some of these pose a risk to the product and patient. That is why regulators from around the world have established bio burden limits, and call for absence of certain microorganisms, such E. coli, Pseudomonas spp., and Salmonella.

This webinar will address the regulatory and industry viewpoints on microbial presence in raw materials. You will learn how to implement a risk management program that assesses the hazard that raw materials poses to your products and manufacturing processes. Ultimately, the focus should be on patient safety and not just a regulatory requirement.

The presenter will provide specific examples, from his experience, during the course to help you better understand and control microbial contamination in raw materials arriving at your facility.

Course Outline:

• What is a biopharmaceutical Raw Material?
• Risks associated with raw materials
• What are the contaminants?
• Do you know where your raw materials come from?
• Manufacturing Processes and control of microbial contamination
• Establishing microbial limits for your raw materials
• Consequences of microbial contamination
• Mitigating the risk

What You Get:

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

Who Will Benefit:

• Quality Assurance
• Quality Control
• Production
• Logistics
• Manufacturing
• Quality system auditors
• QA directors and managers
• Microbiology analysts and technicians
• Consultants
• Regulatory and Compliance Management

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

100% MONEY BACK GUARANTEED

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Subject : Microbiological and Business Risk of not Testing Raw Materials for Microbial Presence

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