e-Learning: Deviations and CAPA

219,95 

e-Learning-Basis-Modul

You will learn why deviation management is necessary and how deviations are handled in practice.

Deviation management, how does it work? What is the purpose of CAPA?
This e-Learning module increases your proficiency in deviation management and CAPA.

Beschreibung

e-Learning: Deviations and CAPA
eLearning-Basis-Modul

 

Deviations must be investigated!

Deviations must be reported and investigated. An assessment is to be made as to whether the deviation has an influence on the product quality. Corrective and preventive measures must be defined, implemented and tracked.

 

EU-GMP-GUIDE: Chapter 1

In this e-Learning module, you will learn about the whole process of deviation testing, from notification to completion of the investigation, in accordance with Chapter 1 of the EU-GMP-Guide. You will also learn the differences between a deviation and a change.

 

Content

  • What is a deviation?
  • What are the differences between deviations and changes?
  • Quality management
  • Documentation of deviations
  • Evaluation of deviations
  • Root cause analysis
  • Corrective and preventive measures, CAPA
  • Completion of the investigation
  • Tracking

Objectives

  • You will learn why deviation management is necessary.
  • You will learn how deviations are handled in practice.
  • You will be able to identify and define Corrective Actions and Preventive Actions (CAPA).
  • You will refresh your GMP knowledge.
  • You will complete a final assessment to obtain a certificate.

Target groups

  • Employees at the operational level who need to report deviations
  • Employees who need to process deviation reports and set CAPA
  • Employees who want to gain an overview of deviation management

Special features

  • Interactive exercises
  • Learn at your own pace
  • From your workplace
  • Glossary with helpful terms and explanations
  • Suitable as initial training, refresher training or retraining
  • With certificate

Industry sectors

  • Drugs
  • APIs
  • Contract manufacturers
  • Contract laboratories
  • Market
  • Distribution
  • Logistics

 

e-Learning: Deviations and CAPA

Referenten

Anna Diehl, PTS Training Service

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