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

Thursday, 05 July 2018  10:00 AM PDT, 01:00 PM EDT

Training Duration = 60 min                  Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

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.

Learning Objectives:

  • 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

Why Should You Attend:

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 bioburden limits, and call for an 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 pose 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.

Instructor

Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas.

Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU.

Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, related to aseptic processing, have been met.