The Pharmaceutical Microbiology Forum Presents



The Bacterial Endotoxin Summit San Francisco



September 11-12, 2006





Conference Description:



The purpose of this meeting is to provide a forum for the sharing of questions, answers and information on the Bacterial Endotoxin Test (BET). The program will range from presentations on technical and compliance-related problems to interactive case studies to round-table discussions. In addition, well have a mini exhibition, where vendors of BET testing reagents and equipment will all have their products on hand for viewing by participants.



Conference brochure attached.



Register online at www.highpeaks.us/2006/BES/registration.htm





Who Should Attend:

BET testing laboratory analysts, managers and decision-makers

Regulatory/compliance specialists

Engineering/validation specialists.



Planned Topic List:

Endotoxin Limits calculation and significance (Interactive)

MVD/MVC uses in validation and routine testing (Interactive)

Gel Clot Test Method advantages and limitations

Photometric methods advantages and limitations

Regulatory/Compliance Issues

USP/EP/JP

Part 11

Aseptic Processing Guideline

Whatever happened to the LAL Guideline?

Test Method Validation

Applications

Depyrogenation

Cleaning Validation

Process Validation

Before We Start FMEA (Interactive)

HACCP Analysis for determination of critical control points (Interactive)

Endotoxin Limits for Non Compendial Materials (Interactive)





Planned Speakers

Karen McCullough, Roche Molecular Systems, MODERATOR

Michael E. Dawson, Ph.D., Associates of Cape Cod, Inc.

Alan Baines, Cambrex Bio Science Walkersville, Inc.

Foster Jordan, Charles River Endosafe

Robert Mello, Ph.D. FDA

Ronald N. Berzofsky, Ph.D., GeneChoice, Consultant



Conference Facilitator:

Karen McCullough, founder, LAL Users Group; Director of Quality Operations, Roche Molecular Systems



Meeting Coordinator:

High Peaks Associates





Register online at www.highpeaks.us/2006/BES/registration.htm