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Conference Description

Welcome to Bacterial Endotoxin Summit 2008.   Previous summits have focused on "Back to Basics" and "GMP issues."  This year we venture into the world of noncompliance, and our theme is “lessons learned”.  What does “noncompliance” mean in the world of Endotoxin? What are the underlying technical or GMP issues that make certain practices noncompliant?

In preparation for this year’s Summit, we’ve researched FDA 483 citations and Warning Letters from the last five years to determine what endotoxin-related philosophies, actions or inactions led to observations.  With the help of our outstanding faculty of experts, drawn from industry, lysate manufacturers and FDA, we’ll examine the technical and compliance issues that could have led to these non-conformances. 

This two-day interactive program includes case studies, problem solving and round table discussions. In addition, we’ll have a mini exhibition, where vendors of BET testing reagents and equipment will all have their products on hand for viewing by participants. 

Topics

• On The Same Page.  This session is devoted to reinforcing basic BET concepts that will be referenced during the Summit

• Out-of-Specification Results and Investigations.  Does the FDA Guidance apply to the BET?  If not, why not?  If so, do we need to make any modifications to the assumptions in the Guidance for the purposes of the Bacterial Endotoxin Test?

• Process Control/ Setting endotoxin limits for in-process testing.  There’s been a lot of “buzz” about process control.  We know how to set endotoxin limits for finished products, but how do we set limits for in process materials?  How do we use these limits to monitor the process?  What happens if we exceed these limits?

• Depyrogenation/Cleaning of vials, stoppers and equipment.  A lot has been published on the use of dry heat to depyrogenated heat stable materials, but what about plastic container/closure systems or rubber stoppers?  Should cleaning of large vessels also assure a three log reduction in endotoxin?  How do we validate endotoxin reduction in cleaning?

• Supplier Qualification of our sourced raw materials, APIs and finished products. Outsourcing is here to stay, and supplier qualification is a major concern for pharmaceutical manufacturers and regulators.  What does one look for when qualifying a supplier for endotoxin content and control?

• Laboratory Variability.  The FDA Guideline says, "manufacturers should assess the variability of the laboratory before any official tests are performed"?  What does that mean?  How can an unstable lab contribute to nonconforming results?  What kind of controls does the lab need to institute?.

• FDA review of submissions and compliance initiatives.  What is happening at FDA with regard to review of submissions and compliance initiatives?

• Sampling for BET.  What is statistically valid sampling?  Is any BET sample statistically valid? Certainly 3 units (BME) is not a statistically valid sample - how do we support that?  What about the 10 samples for devices?  What are the advantages and disadvantages of pooling?

Speakers

• Karen McCullough, MMI Associates/LAL Users Group, Moderator  

• Alan Baines, Global Director, Rapid Testing Systems, Lonza Bioscience 

• Ronald Berzofsky, PhD, General Manager, LAL Division, Wako Chemicals USA, Inc.  

• Mick Dawson, PhD, Director of Regulatory Affairs, Associates of Cape Cod

• John Dubczak, Production Production Manager, Charles River Endosafe

• Robert Mello, PhD, Reviewer, New Drug Microbiology Staff, Office of Pharmaceutical Science/CDER, US Food and Drug Administration 

Venue

Sheraton Gateway Hotel (SFO)
600 Airport Boulevard
Burlingame, CA 94010

Reservations may be made by calling (800)325-3535.  Please mention “Bacterial Endotoxin Summit”  to receive group rate of $139/night.  This rate expires October 13, 2008.

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:

• Be able to explain the critical aspects of demonstrating an effective depyrogenation treatment.

• Critically review potential contributions of endotoxin monitoring strategies to enhancing control of manufacturing processes.

• Develop and evaluate alert and action levels for endotoxin in the production process.

• Design and execute investigations out-of-specification endotoxin endotoxin results.  This will include applicability of FDA's OOS guidance document and regulatory strategies.

• Understand how to control endotoxin endotoxin testing in the laboratory to minimize the occurrence of nonconforming results.

• Develop an endotoxin inspection strategy of outsourced results.

• Discuss recent FDA 483 observations that relate to bacterial endotoxin control, and be able to apply these to general issues of manufacturing control.

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

We 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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