Training Course Syllabus:
Microbiological and Business Risk of not Testing Raw Materials for Microbial Presence
Objectives of the Presentation
- 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 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.