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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 10

7:30-8

Registration and Continental Breakfast

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 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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We are very excited to announce this year's PMF Fall Forum, "Current Trends in Pharmaceutical Microbiology".  Leading industry experts will present and discuss topics relating to current regulatory, compendial and enforcement trends in Quality Control Microbiology.

Our industries, relying on compliance with current Good Manufacturing Practices, are subject to the ever-evolving continuum of our regulatory environment.  This conference will provide you with a perspective on several current trends relating to QC Microbiology.  We are privileged to have well-recognized industry Subject Matter Experts present their knowledge and experiences with tackling the challenges associated with these trends, ranging from QC Microbiology data integrity to historical and current regulatory enforcement actions relating to Burkholderia cepecia complex.  Effectively recognizing and addressing these current trends is key to cGMP compliance.

“Current Trends in Pharmaceutical Microbiology” will provide an excellent opportunity for participants to acquire the knowledge and learn the skills necessary for managing these challenges.

 Read more and register here.

 

Schedule 

Monday, November 12, 2018

8:00 - 8:30 am

Registration and Full Breakfast Buffet

8:30 - 9:00 am

Welcome – Robert Westney

9:00 - 10:30 am

Utilizing an Organized Data Driven Approach to Investigate, Solve Problems, and Demonstrate Process Control – Matthew Paquette, Product Specialist, Charles River

10:30 - 11:00 am

Break

11:00 am - 12:00 pm

Establishing Environmental Monitoring Alert and Action Levels: A Novel Case Study – Doug Schmidt, Director of Quality Control, Exela Pharma Sciences LLC

12:00 - 1:00 pm

LUNCH

1:00 - 2:00 pm

Burkholderia cepacia complex: Current Regulatory Trends – Bob Westney, Director of Quality and Operations, Cryologics Inc.

2:00 - 3:00 pm

Manufacturing Quality Product in an Aging Facility – Randy Hutt, Associate Director, Microbiological Services, Luitpold Pharmaceuticals

3:00 – 3:30 pm

BREAK

3:30 - 5:00 pm

Monitoring of Purified Water Systems – Tony Cundell, Ph.D., Consulting Microbiologist

5:00 - 6:30 pm

RECEPTION

 

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

·         Brian Beck

3:30

Conference Concludes