The Conference

The FDA LAL Guideline is 20 years old! While the USP is clearly the most current and technically correct testing document, there
are many GMP topics in the Guideline and beyond the Guideline that still need discussion. Last year, the BES explored the basics of the LAL test. The focus of this years meeting is to provide a forum for the sharing of questions, answers and information on GMP aspects of the Bacterial Endotoxin Test (BET). We are fortunate to have a distinguished panel of LAL experts to present on many GMP-related topics. This two-day interactive program includes case studies, problem solving and 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.



Presentations

The Big Moving Parts of Depyrogenation -
Ron Berzofsky, Ph.D., LAL Consultant

How Much Testing is Enough? Determining Critical
Control Points for Process Control -
Karen McCullough, MMI Associates

Data Analysis: Setting Action and Alert Limits -
Allan Baines, Lonza

Water System Failure Whats the risk? -
Mick Dawson, Ph.D., Associates of Cape Cod

OOS and Investigation Does the 2006 FDA OOS
Guidance Apply to the BET? -
John Dubczak, Charles River Endosafe

BET Questions CMC Submission and 483 Concerns -
Robert Mello, Ph.D., FDA Reviewer (invited)

Whats new at Associates of Cape Cod?

Whats new at Charles River Endosafe?

Whats new at Lonza?


CEU & Learning Objectives
The participants in this conference will receive 1.0 CEU IACET-certified credit (10 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.


At the completion of the conference 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 and develop and evaluate alert and action levels for endotoxin in the production process. In addition, they will be able to design and execute investigations into microbiological issues of water testing. This will include applicability of FDA's OOS guidance document and regulatory strategies as well as 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 and Compliance Personnel responsible for auditing of manufacturing facilities and QA and Contract Microbiology Laboratories.

Engineering/validation Specialists


Weblink -
2007 PMF Bacterial Endotoxin Summit