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PMF Bacterial Endoxin Summit 2018

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 10

7:30-8:00

Registration and Hot Breakfast Buffet

8:00-8:45

Welcome - Karen McCullough, MMI

8:45-10:00

Drug case study – Jim Cooper, Pharm D., Endotoxin Consulting Services

10:00-10:15

Break

10:15-11:30

Water case study- John Dubczak

11:30-12:30

Lunch

12:30-1:45

Limits for Combination Products- Veronika Wills 

1:45-3:00

Controlling the lab – Kevin Williams

3:00-3:15

Break

3:15-4:30

MAT –Tammy Thurman

4:30-4:45

Wrap up

5:00-6:30

Reception

 

Time

September 11, 2018

8:00-8:30

Registration and Hot Breakfast Buffet

8:30-8:45

Introduction
Karen McCullough, MMI

8:45-10:00

Current USP Perspectives on 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