Skip to content

Quality Risk Management in Pharma

Online Training Course for Self-Paced Learning.

Web-based interactive training course for to gain understanding for the typical steps of a quality managment (QM) process and to become familiar with the Failure Modes and Effects Analysis (FMEA) as one of the most frequently used tools for a (quantitative) risk evaluaton.

Tools and Learning Techniques

Register Interest

If you are interested to register for the workshop, please contact us at info@phact.ch.

Please indicate whether you are interested to register for an individual use or for a team.

Organisational

Single web-based interactive training course for self-paced learning.

The learning objective of the course is to gain understanding for the typical steps of a quality management (QM) process and to become familiar with the Failure Modes and Effects Analysis (FMEA) as one of the most frequently used tools for a (quantitative) risk evaluaton.

The online course is intended for staff members of development, production, drug regulatory affairs who want to become familiar with the principles of Quality by Design (QbD).

English

Dr. Barbara Jentges, Phact GmbH

The basic principles of Quality Management (QM) that apply to the pharmaceutical industry are laid down in the International Council for Harmonization (ICH) Guideline Q9 that in turn is based upon the ISO/IEC Guide 51. QM is a “systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the lifecycle.” The QM process is categorized into the three sub-processes risk assessment, risk control and risk review. The learning contents are structured into four units that guide through the QM process based on a practical example from everyday lifedie Kapit. It is therefore recommended to study the units one after another.

  • Quality Management – An Overview
  • Risk Assessment
  • Risk Control
  • Risk Review

At the end of the course the knowledge can be tested in an interactive quiz. During the usage period, the lecture can be interrupted, continued and repeated at will.

60 days from delivery of access data.