Opulus

Keresés: 
Kompetencia oktatás, SOP management
LAL-endotoxin mérés
LAL-endotoxin mérés modellezése
LAL Proficiency Teszt


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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.

 
   
Frissítve:2006. 03. 08.
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