LAL User's Group 2010 Bacterial Endotoxin Summit
Understanding Variability
in the BET Laboratory

March 22-23, 2010

San Francisco, CA

Anyone who does Bacterial Endotoxins Test knows terms such as, "+/- one twofold dilution of label claim" or "recovery of 50-200% of nominal spike value."  What contributes to these large recovery ranges?  Why is it that test results between different assay methods or within an assay method don't always "match"?  What are the sources of test variability?  How can the laboratory control variability to assure consistently accurate results? 

Through a combination of lecture and hands-on workshops, participants will work with industry leaders to understand indicators of variability in BET test methods and data, and to identify pragmatic and value-added procedures that can be applied to the BET lab to control variability.  

Major themes for identifying and controlling variability will include:

• test method variability including comparison of different test methods (gel and quantitative)
• assay variability including the effects of test interferences and standard curves
• laboratory variability including instrumentation, reagents, consumables, analysts technique
• process variability including the identification of critical manufacturing steps
• the importance of preparatory testing, assay controls and training to limit variability
• writing submissions that demonstrate control of variability

The LAL User's Group and PMF are providing an opportunity for the membership to meet in small groups with international academic and industry experts.

Come and pose your questions to industry thought leaders in a small and personal setting.  This is an unparalleled opportunity to benchmark your practices not only against current regulatory expectations, but also against other companies in the industry.  FDA has been invited to participate in this meeting.

This conference will be moderated by Karen Zink McCullough.  Karen is a veteran of LAL compliance and technology.  She has been working with the bacterial endotoxins test since 1973 and in 1975 and she published the first paper on the use of BET in small volume parenterals.  She also was the driving force organizing the LAL Users Group.  Karen is a highly regarded GMP trainer and organizer of professional development programs. 

Karen will lead a team of nationally known experts over the course of the two days, allowing all participants opportunity to address their concerns with several experts present.

Please let us know if you are interested in being informed when registration opens for this conference.