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EVENTS

 

The 2018 Bacterial Endotoxin Summit (BES) is the 12th annual meeting in a series devoted to the dissemination of non-commercial, scientific information on various topics of interest to scientists interested in the Bacterial Endotoxins Test. 

 Join this hands-on  workshop to unearth clues and execute an endotoxin failure (OOS) investigation for a virtual biologic combination product.  A faculty of top endotoxin testing experts will work with participants to understand the following topics for determining the root cause:

  • Organizational strategies for investigation OOS
  • Calculating endotoxin limits and testing strategies for medical devices and c combination drugs
  • Depyrogenation of product contact components
  • Where does endotoxin come from?
  • Points to consider for BET testing of biological product formulations
  • Monocyte Activation Testing - how does this fit in?

Learn more here.

Register here.

 

Schedule 

Time

September 11, 2018

8:00-8:30

Registration and Continental Breakfast

8:30-8:45

Introduction
Karen McCullough, MMI

8:45-10:00

Depyrogenation –

Radha Tirumaili

10:00-10:15

Break

10:15-11:30

Growth and Endotoxin Production –

Elaine Spiers

11:30-12:30

Lunch

12:30-1:45

Structuring an OOS-

Allen Burgenson

1:45-2:45

Work

2:45-3:00

BREAK

3:00-4:00

Discussion

4:00

Conference Ends

 


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Schedule 

Tuesday, November 13, 2018

8:00 - 8:30 am

Registration and Full Breakfast Buffet 

8:30 - 10:00 am

QC Microbiology: How Automation and Integration Enforce Data Integrity – Rob Lutskus, Global Product Delivery Manager – Informatics, Lonza

10:00 - 10:30 am

BREAK 

10:30 - 11:30 am

Use of the USP for Training, Standards, and Best Practices in Pharmaceutical Microbiology – Don Singer, Senior Fellow, Microbiology, Biopharmaceutical GMP Operations, GlaxoSmithKline

11:30 am -12:30 pm

LUNCH 

12:30 - 1:30 pm

Surviving the Microbiology Lab Audit - Tips from the Trenches – Rick Jakober, Vice President of Laboratory Services, Perritt Laboratories, Inc.

1:30 - 2:00 pm

BREAK 

2:00 - 3:00 pm

Identification Techniques of Environmental Isolates – Brian Beck, Ph.D., VP of Research and Development, Microbiologics Inc.

3:00 - 3:30 pm

Panel Discussion

·         Robert Westney

·         Matthew Paquette

·         Doug Schmidt

·         Tony Cundell

·         Randy Hutt

·         Rob Lutskus

·         Don Singer

·         Rick Jakober

·         Megan Murn

3:30

Conference Concludes