Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

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.

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.

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

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