1. Risk of Objectionable Microorganisms in Biopharmaceuticals
This webinar on objectionable microorganisms will discuss the most current practices that define an
objectionable microorganism and will provide a practical approach to determining just how
objectionable it really is. You will learn how to mitigate the risk of presence of objectionable
microorganisms in medicinal products.
Why Should You Attend:
This lack of clear guidance from the regulators has not stopped the agency from placing a great burden
upon the biopharmaceutical industry to ensure medicines are free from objectionable microorganisms.
This is clearly evidenced by the recent recall data that show an increase in microbiologically-related
causes. Objectionable microorganisms are especially prevalent in the recalls of non-sterile drug
products. Drug manufacturers need to be concerned about the presence of objectionable
microorganisms not only because of potential health hazards they may pose for patients but also due to
the fact that their presence may lead to product spoilage and deterioration, which further places
increased pressures on the bottom line.
In this webinar you will learn how to help your organization get a better handle on what is an
“objectionable microorganism, ” exactly how “objectionable” it really is and what you can do to
minimize the risk if you find one in your process or product.
Areas Covered in the Session:
Review of recent recall data
Definitions of Objectionable Microorganisms
What is the risk if you find one?
How bad the microorganism is depends on where you found it
Examples of Objectionable Microorganisms
Setting up an applicable risk assessment strategy
Who will benefit:
Manufacturing
Quality system auditors
QA directors and managers
Microbiology analysts and technicians
Consultants
Regulatory and Compliance Management
For more details visit us at:
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703185?
channel=SBM_organic