Quality Risk Management

Quality Risk Management course in the pharmaceutical industry
 

Target audience:

This course is designed for new employees in the pharmaceutical or life sciences sector working in development, manufacturing, engineering and validation. Also welcome are employees from medical environments, such as hospitals, who wish to refresh or expand their knowledge in the area of Quality Risk Management (QRM).
 

Learning Objective:

Are you already working in a GMP environment? Then you will undoubtedly come into contact with Quality Risk Management (QRM). In the training “Quality Risk Management (QRM)” you will learn all about the legal requirements around QRM and how to perform risk analyses using the FMEA method. This interactive training will ensure that you quickly master the technique and can immediately apply it in your daily work.

Program:

• Legislation around QRM (ICH Q9).
  • Understanding the international guidelines and regulations underlying QRM.
• Quality Risk Management process step by step.
  • A detailed explanation of the complete QRM process, from identification to mitigation.
• QRM - FMEA method
  • In-depth introduction and explanation of the FMEA (Failure Modes and Effects Analysis) method, an essential part of risk management in life sciences
• Workshop: application of QRM - FMEA
  • Practical sessions in which you directly apply the learned theory to realistic cases, so that you learn to use the method effectively.
• Introduction to CSS (Contamination Control Strategy).
  • Brief introduction to contamination control strategies, an important aspect of product quality and patient safety.

Certificate:

The course concludes with an exam. If you pass, you will receive an official certificate.

Location:

The training will take place in the GxP Academy at Advipro headquarters: Wechelsebaan 143 unit 13, 2275 Lille.

Additional information:

Are you a student? Don't hesitate to contact us so we can discuss the possibilities.

Enroll now and strengthen your skills in Quality Risk Management!