Why I Should Test Raw Materials for Microbial Presence and What Are The Microbiological and Business Risks If I Choose Not to?

Henry Urbach

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In order to reduce cost of production, many organizations are reexamining the need for testing raw materials. Many manufacturing processes provide a hostile environment for the growth of microorganisms and low risk of microbial contamination. This is true of raw materials that are chemical synthesized. The same cannot be said of those materials that are sourced from natural materials. Moreover, some microorganisms survive even in harshest environments. Each organization must assess the risk between reliance on its processes to remove microbial contaminants and the risk of potential recalls and/or patient welfare. Raw materials are often the major source of microbial contamination that is introduced into the manufacturing process, and 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 absence of certain microorganisms. The presence of these microorganisms does not only pose threat to the patient in terms of health, but it also causes product spoilage.

Course Objective

This webinar will address the regulatory and industry viewpoints on the subject, and the rationale why each organization, as part of its risk management program, should assess the hazard that raw materials pose to its products and manufacturing processes. Ultimately, the focus should be on both patient safety and regulatory requirements.


Course Outline

  • What is a raw material and where it comes from
  • Regulatory expectations and requirements
  • Industry perspective
  • Processing of raw materials during manufacturing
  • Risks associated with raw materials
  • Determining acceptance criteria
  • Managing your suppliers
  • Examples from recent history


Target Audience

  • Quality Assurance personnel
  • Quality Control personnel
  • Microbiology professionals
  • Regulatory and Compliance Management
  • Senior Management responsible for making final decisions

Webinar Events
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Training CD-USB

Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment

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Recorded video

Recorded video session

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Speaker: Henry Urbach,

Henry Urbach is the founder of GMP Training, Development and Consulting. GMP TDC LLC is a New York-based consulting organization serving Life Sciences industries. Henry has 25+ years of Life Sciences experience having held positions of increased responsibility in GMP Training and QC Microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of a post-regulatory action remediation, and developing a contamination control and environmental monitoring training program for major pharmaceutical and biotechnology organizations. He is a dynamic speaker specializing in FDA and ICH compliance. He is also a CQA Certified Quality Auditor. His technical education is further complemented by his BA degree in Biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP TEA, a national organization of Life Sciences training professionals.


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