LAL Basics

Introduction

Bacterial endotoxin is one of the most troublesome contaminants and critical quality parameters in the pharmaceutical, biotechnology, and medical device industries. It also represents a unique challenge in quantitative determinations, for example:

• Frequently, very high sensitivities are specified (0.001 EU or about 100 femtogram),
• Frequently, a very wide dynamic range (6-log) is utilized, and
• High throughput requirement is frequent.

Course Description

LAL BASICS provides a solid foundation for the Bacterial Endotoxin Test (BET). This core-competency-course is multimedia enhanced, and includes a pre-qualification requirement, competency testing, qualification examination, training administration, scheduling, evaluation, and competency validation functions. You will also get the benefit of the latest ICH requirements for BET. All CACTUS competency training courses are scaleable in various configurations from a single workstation to Internet and Intranet environments under Win98/NT and Windows2000 operating systems.

CACTUS Integration

LAL BASICS is integrated into the following CACTUS sub-systems:

• TIMS (Training Information Management System) with 21 CFR Part 11 compliant module
• METAN (Competency Metrics and Analysis) with 21 CFR Part 11 compliant module.

Course Content

• Pre-Qualification Requirement
• Introduction
• What is LAL?
• What is Endotoxin?
• Basis of the LAL Test
• Good Practices for OOS
• ICH: Pharmacopeal & Acceptance Criteria
• SOP: Execution of the LAL Test
• Good Documentation Practice
• Summary

Learning Objectives

At the completion of this course the trainees will understand:

• Background and concept of the BET and LAL
• Critical issues relative to BET
• New ICH requirements
• Requirements for proper execution & documentation.

Audience

This course is intended for all levels of technical personnel working in QC/QA.