Bacterial Endotoxin Testing
Date : 06 December 2018
Time : 02 : 00 PM EST
Duration : 60 Minutes
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Quality Control, 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.
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.
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.
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.
- 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.
- The different types of systems for testing LAL.
- Knowing which system is best for you and your product.
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.
Who Should Attend
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Manufacturing engineers
- Quality engineers
- Quality auditors
- Quality control personnel
- Microbiology specialists
- R & D personnel
- Speaker: CARL PATTERSON
- Webinar Code: PATT-0006