Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms? (CO2009)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Aug 28, 2009 End Date/Time: Aug 28, 2009
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Why should you Attend:
Many companies are in a survival mode and need to reduce costs and improve efficiencies wherever possible. One area that seems straightforward is testing raw materials for microbial integrity. Why bother? Won't the manufacturing process kill any microbes that might be residing in the materials? Possibly, yes. But what about an organism that survives, contaminates a product and causes a patient to die? Is your company prepared to accept the consequences of the FDA, lawyers and families demanding restitution? Is your company ready to thwart the assault from the media? How long can your company survive if it has to recall its products and shut down for months before it can start producing again? Are risky cost reductions too risky? Find out the real implications of saving a few cents and if it's truly worth the risk.

Raw materials are receiving tremendous scrutiny from the FDA and other regulatory agencies around the world and have been earmarked as a potential source of uncertainty in the manufacturing of pharmaceuticals, biopharmaceuticals, nutritional supplements and cosmetics. However a prevailing thought is that the processing steps of manufacturing are severe enough to eradicate most microorganisms that may be present in the raw materials. So why worry about the raw materials? Why test them if the manufacturing process will eliminate them? This webinar will present reasons why it's in the best interest of a company to test their raw materials: not only from a regulatory perspective but also from a safety and sound business perspective.

Areas Covered in the seminar:

* How manufacturing processes eradicate microbes.
* Why some microbes escape the manufacturing process.
* Some really bad microorganisms.
* A changing population.
* Recent recalls and their disastrous consequences.
* The true cost of cost reductions.


Additional Information

Who will benefit: * Quality system auditors * Senior Management responsible for making final decisions * QA directors and managers * Information Technology managers and personnel * Microbiology analysts and technicians * Consultants * Regulatory and Compliance Management