A 21 CFR Part 11 compliant Core Competency Course
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,
- High throughput requirement is frequent.
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.
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
- Pre-Qualification Requirement
- 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
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.
This course is intended for all levels of technical personnel
working in QC/QA.