LAL Intermediate

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 method development and validation for quantitative analysis, 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
• The analytical sub-systems, such as instrumentation, supplies, and reagents are highly vendor dependent.

Course Description

LAL-INTERMEDIATE provides a solid foundation for method development, method validation, and method maintenance in Bacterial Endotoxin Testing (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-INTERMEDIATE 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
• LAL-Endotoxin Cascade Reaction
• LAL-Endotoxin Test Interferences
• Good Sampling - Sampling Requirements Analysis
• Calibration & Qualification Requirements
• GMP - QC Considerations
• Method Validation
• SQC - Method Maintenance
• Vendor Qualification Considerations
• SOP Development & Specification
• Summary

Learning Objectives

At the completion of this course the trainees will understand:

• The method life cycle concept and implementation for quantitative BET
• The application of SQC for method maintenance
• Vendor qualification requirements
• The development and maintenance of suitable SOP.

Audience

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