Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

MessageThis Webinar is over
Date Nov 16, 2017
Time 01:00 PM EDT
Cost $250.00
cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable so as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.

Objectives of the Presentation
This course is designed to introduce LAL methodologies to technicians who are new to LAL testing. Topics include:
  • Endotoxins - What they are, where they come from, and why they are important
  • LAL - An overview of the LAL/endotoxin reaction, with emphasis on sources of interference
  • Detailed demonstration of the test methods including a discussion of laboratory set-up, materials, and aseptic techniques
  • Specimen handling and preparation for test
  • Practical approaches to specimen characterization
  • Technician and laboratory certifications and protocols for validation of the LAL test
This course is designed to provide the experienced technician with a more detailed understanding of how an LAL testing program can be applied to quality control.

Why Should you Attend
This 60-minute accredited training will discuss the requirements of current USP <85> Bacterial Endotoxin Test (BET) and European Pharmacopoeia (Chapter 2.6.14). It will address the different LAL testing methodologies and how to choose the best test method applicable to the product type. This webinar will outline the importance, regulatory and testing requirements of products for compliance by applying the sequential steps in testing the product to rule out the presence of endotoxins.

This webinar will provide a great resource to companies in the Pharmaceutical, Biotechnology and Medical Device Industries that manufacture cGMP products requiring bacterial endotoxin release assay.

Areas Covered
  • Introduction to current USP <85> Bacterial Endotoxin Test
  • Types of Bacterial Endotoxin Test Methodologies
  • Advantages and Disadvantages of Each Methodology and Choosing the Appropriate Method
  • Initiating a Bacterial Endotoxin Test-Initial Considerations
  • LAL Testing Materials and Reagent Qualification
  • Products Receipt, Handling and Storage
  • Product Processing
  • Handling, Investigating and Resolving Failure and Out of Specification (OOS) Results
  • Relationship of Endotoxin Test (LAL) with other Production and Process Controls
Who will Benefit
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality control personnel
  • Microbiology specialists
  • R & D personnel
Instructor Profile:
Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas. Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, related to aseptic processing, have been met. 


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