- Speaker : Carl Patterson
- Session Code : CNAPR2921
- Date : 29th April 2021
- Time : This Event is Over and the Recorded Copy is Available
- Duration : 60 Mins
Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program
Overview:
Bacterial Endotoxin Test (BET) is a vital safety requirement in the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and the medical device quality system regulations. A solid grasp of the concept of this critical release assay, its application and importance to the manufacture of cGMP product is paramount.
This helps avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.
This webinar has been designed to provide
the experienced technician with an extensive understanding of how an Limulus
amebocyte lysate (LAL) testing program can be applied to quality control so
that regulatory requirements enforced by the EU and the FDA are met.
Areas Covered in the Session :
- 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
Why You Should Attend?
The current requirements of 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.
Who Should Attend:
- Quality
Assurance Departments
- Research
and Development Departments
- Regulatory
Affairs Departments
- Quality
Control Departments
- Manufacturing
Departments
- Engineering
Departments
- Compliance
Departments
- Quality Auditors
- Microbiology Specialists
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.
Enrollment Options
Tags: Bacterial Endotoxin Testing, BET, Carl Patterson, amorit education, webinar