Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program
Speaker: Carl Patterson
Speaker Designation: Director Of Quality at LATITUDE Pharmaceuticals, Inc.
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Speaker: Carl Patterson
Speaker Designation: Director Of Quality at LATITUDE Pharmaceuticals, Inc.
The Bacterial Endotoxin Test (BET) is an indispensable safety measure governed by the current good manufacturing practice (CGMP) regulations for pharmaceutical products and medical devices. A comprehensive understanding of this critical release assay, its implementation, and its significance in the production of cGMP goods is critical. It aids in reducing costly errors, batch disposals, expensive failure investigations, and delays in product release, all of which have plagued some manufacturers in the past.
This informative webinar is tailored to provide seasoned technicians with in-depth knowledge of how a Limulus Amebocyte Lysate (LAL) testing program can be leveraged for quality control to conform to regulatory requirements enforced by the FDA and EU.
The current requirements of the USP <85> Bacterial Endotoxin Test (BET) and European Pharmacopoeia (Chapter 2.6.14) will be discussed in this 60-minute webinar. 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 significance, regulatory, and testing requirements of products for compliance by applying the sequential steps in testing the product to rule out the presence of Endotoxins. Companies in the Pharmaceutical, Biotechnology, and Medical Device Industries that manufacture cGMP products requiring bacterial Endotoxin release assay will greatly benefit from this program.
This course is designed to introduce LAL methodologies to technicians who are new to LAL testing. Topics include:
This course also provides the experienced technician with a more detailed understanding of how a LAL testing program can be applied to quality control.
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. To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called aseptic-process.net, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector. Recently, he is in the process of creating webinars so he can share pertinent information about pharmaceutical manufacturing from a microbiological perspective. 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.