Conference Description

Anyone who performs the Bacterial Endotoxins Test has heard terms like "+/- 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? 

The 2010 Bacterial Endotoxin Summit will help you determine the sources of test variability and control this variability to ensure consistently accurate results.

Through a combination of lecture and hands-on workshops, you'll work with industry leaders to understand indicators of variability in the LAL test methods and data, and to identify pragmatic and value-added procedures to control this variability.  

• 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, analyst's 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

Speakers:

• Karen McCullough, LAL User's Group
• Alan Baines, Lonza
• Ronald Berzofsky, Ph.D., Wako
• Mick Dawson, Ph.D., Associates of Cape Cod
• John Dubczak, Charles River Laboratories
• Robert Mello, Ph.D., FDA/CDER

As an added benefit, the LAL User's Group is providing an opportunity for the membership to meet in small groups with internationally recognized experts in the Bacterial Endotoxin Test.

Come and pose your questions to industry thought leaders in a small and personal setting -- 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.

Venue

Hilton San Francisco Airport Hotel
600 Airport Boulevard
Burlingame, CA  94010-1978

Hotel reservation information will be sent to all registrants once the minimum enrollment has been achieved.    

CEU & Learning Objectives

The participants in this conference will receive 1.5 CEU IACET-certified credit (14.5 contact  hours)  upon successful completion of the conference. 

The participants are expected to actively participate in discussion and questions for the conference - the unique strength of this conference is the opportunity to discuss the science behind the regulations.  

The participants will:  

• understand and recognize sources of variability in the Bacterial Endotoxins Test

• understand how to control variability in the Bacterial Endotoxins Test

• know how to document control of variability in FDA drug submissions

• understand test method variability including comparison of different test methods (gel and quantitative)

Who Should Attend

• Microbiology Laboratory supervisors and Microbiologists responsible for testing and release of Pharmaceutical, Parenteral and Medical Device products. 

• Regulatory, QA, QC and Compliance Personnel responsible for auditing of manufacturing facilities and Contract Microbiology Laboratories. 

• Engineering/validation Specialists

Conference Organizers

• The LAL User's Group

• High Peaks Associates (meeting coordinators)

The LAL User's Group would like to thank Associates of Cape Cod, Charles River Endosafe, Lonza Bioscience and Wako Chemicals, USA for their continued support of the Bacterial Endotoxin Summit  

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