Schedule

2008 PMF Bacterial Endotoxin Summit 

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Previous summits have focused on "Back to Basics" and "GMP issues."  This year we venture into the world of noncompliance, and our theme is “lessons learned”.  What does “noncompliance” mean in the world of Endotoxin? What are the underlying technical or GMP issues that make certain practices noncompliant?

In preparation for this year’s Summit, we’ve researched FDA 483 citations and Warning Letters from the last five years to determine what endotoxin-related philosophies, actions or inactions led to observations.  With the help of our outstanding faculty of experts, drawn from industry, lysate manufacturers and FDA, we’ll examine the technical and compliance issues that could have led to these non-conformances. 

This two-day interactive program includes case studies, problem solving and round table discussions. In addition, we’ll have a mini exhibition, where vendors of BET testing reagents and equipment will all have their products on hand for viewing by participants.