Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms

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 microflora. Some of these pose a risk to the product and patient.

This webinar will address the regulatory and industry viewpoints on the subject of testing raw materials for microorganisms. Each organization, as part of its risk management program, should assess the hazard that the raw materials pose to its products and manufacturing processes. Ultimately, the focus should be on patient safety and not just a regulatory requirement.

Attendees will learn how to assess the risk between reliance on your processes to remove microbial contaminants and the risk of potential recalls and/or patient welfare. You will learn how to effectively manage the risk of contamination from raw materials.

Areas Covered in the Webinar:

• What is a raw material?
• Regulatory perspective
• Industry view
• Consequences of contamination
• Risk management

Who Will Benefit:

This training webinar has been designed for the following personnel in pharmaceutical, biopharmaceutical and food manufacturing companies:

• Quality assurance personnel
• Quality control personnel
• Microbiology professionals
• Regulatory and compliance management
• Senior management
• Testing and validation professionals

Instructor Profile:

Henry Urbach, is the founder of GMP Training, Development and Consulting, GMP TDC LLC, a New York-based consulting organization serving the life sciences industries. He has over 20 years of life sciences experience having held positions of increased responsibility in GMP training and QC microbiology. His experience includes managing and implementing CGMP compliance and quality systems training for major pharmaceutical and biotechnology organizations. He is a dynamic speaker specializing in FDA and ICH compliance. He is a certified quality auditor. His technical education is further complemented by his BA degree in biology and MBA, which provide both a scientific and business insight. He is a member of the ASTD, ASQ, and GMP TEA, a national organization of life sciences training professionals.

Topic Background:

In order to reduce cost of production, many organizations are re-examining 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 the 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.

Some of the microorganisms in raw materials pose a risk to product and the patient. That is why regulators from around the world have established bioburden limits, and call for absence of certain microorganisms, such E. coli, Pseudomonas spp., and Salmonella. The presence of certain microorganisms does not only pose threat to the patient in terms of health, but it also causes product spoilage. Through their natural degradative capabilities, they cause deterioration of pharmaceuticals.

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