Regulatory and Testing Requirements of Bacterial Endotoxin Testing (BET) using LAL

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.

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.

Areas Covered in the Webinar:

1. Introduction to current USP <85> Bacterial Endotoxin Test
2. Types of Bacterial Endotoxin Test Methodologies
3. Advantages and Disadvantages of Each Methodology and Choosing the Appropriate Method
4. Initiating a Bacterial Endotoxin Test-Initial Considerations
5. LAL Testing Materials and Reagent Qualification
6. Products Receipt, Handling and Storage
7. Product Processing
8. Handling, Investigating and Resolving Failure and Out of Specification (OOS) Results
9. 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

Carl Patterson
QA Team Lead, Bachem

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, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.

Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.

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