Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program
Duration : 60 Minutes
Carl Patterson, MS, SSGB, SSBB,
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However Read more
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.
Course Objectives:
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 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.
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Manufacturing engineers
• Quality engineers
• Quality auditors
• Quality control personnel
• Microbiology specialists
• R & D personnel
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
