Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program
Duration: 60 Minutes
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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.
05/17/2018 10:00 AMTraining Topic: Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL ProgramInstructor: Carl Patterson
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.
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
Handling, Investigating and Resolving Failure and Out of Specification (OOS) Results
Relationship of Endotoxin Test (LAL) with other Production and Process Controls