Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

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. 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.

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.

Areas Covered in the Webinar:

• 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

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel in pharma, biopharma and food manufacturing companies:

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

Henry Urbach
Principal, GMP TDC LLC

Henry Urbach, is the founder of GMP Training, Development and Consulting, GMP TDC LLC, a New York-based consulting organization serving Life Sciences industries. He has 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 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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