Advanced LAL Measurement Practices

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 for analysts in the selection and integration of suitable sub-system modules (DQ) to assure reliability & robustness to minimize OOS problems, for example:

• Selection of a suitable microplate reader (photometer) for the required sensitivity and accuracy,
• Selection of a suitable LAL-technique for the required sensitivity and accuracy,
• Selection of a suitable LAL reagent relative to the above,
• Selection of a suitable software for best-measurement, including integration and OOS minimization.

Course Description

LAL-ADVANCED provides advanced tools for designing an optimum & reliable Bacterial Endotoxin Testing (BET) test system. 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-ADVANCED 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
• Simulation of LAL-Endotoxin Kinetics
• Design Qualification of LAL-Endotoxin Kinetics System
• Chemometric Applications to LAL Kinetic Testing
• Signal Processing Applications to LAL Kinetic Testing
• OOS Modelling & Tracking
• Quality Improvement Methodologies - EQU
• Integrating Competencies & Best Measurements Practices
• Evolving Technologies
• Summary

Learning Objectives

At the completion of this course the trainees will understand:

• DQ simulation concept and implementation relative to quantitative BET
• The application of signal processing and chemometrics to reduce OOS problems
• Integration of SOP and competencies
• Evolving technologies to be considered in DQ.

Audience

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