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
- Menu bar for easy naviation on each page of the course
- Numerous pop-ups for further information
- Numerous figures for easy understanding of complex matters
- Glossary (hyperlinked)
- Bibliography
- Interactive quiz with control of success
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.
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.