Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program 2019

Topics

• Types of Bacterial Endotoxin Test Methodologies
• Introduction to current USP 85 Bacterial Endotoxin Test
• Initiating a Bacterial Endotoxin Test-Initial Considerations
• Advantages and Disadvantages of Each Methodology and Choosing the Appropriate Method
• Products Receipt, Handling and Storage
• LAL Testing Materials and Reagent Qualification
• Handling, Investigating and Resolving Failure and Out of Specification (OOS) Results
• Product Processing
• Relationship of Endotoxin Test (LAL) with other Production and Process Controls

Who should Attend

• Research and Development Departments
• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Engineering Departments
• Manufacturing Departments
• Quality Auditors
• Compliance Departments
• Microbiology Specialists