Good Pipetting Practices
A 21 CFR Part 11 compliant Core Competency Course
Introduction
Pipetting is one of the most frequently performed laboratory
operations both in research and quality control. Recent advances in applications
and the demand for high throughput processes on the one hand, while the demand
for accuracy and reproducibility on the other hand, require a solid
understanding by analysts of good pipetting practices. Good pipetting practice
(GPP) can significantly help in the improvement of quality, efficacy, and
efficiency of your laboratory output, for example:
- GPP can prevent CTD (Cumulative Trauma Disorder),
- GPP can improve accuracy and reproducibility, significantly
reduce your OOS problems and,
- GPP can increase the throughput.
Course Description
GPP provides a solid foundation to improve quality and
regulatory compliance. 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. A separate chapter is included for special applications,
including microplate application and LAL testing. 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
Good Pipetting Practice 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
- Background
- Modern Pipetting Tools
- Modern Pipetting Methodologies
- DQ and Selecting your Pipet
- IQ-OQ-PQ Requirements
- Maintenance & Calibration
- Special Applications
- Writing your SOP
- Summary
Learning Objectives
At the completion of this course the trainees will understand:
- How to select a suitable pipet and pipetting methodology for
their requirement
- How to install and qualify your pipets
- How to maintain & calibrate your pipets for best result
- How to write an effective SOP.
Audience
This course is intended for all levels of technical personnel
working in QC/QA.
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