Quality Risk Management is an interactive training. During this training we will discuss the application of QRM.



We answer various questions, such as: What is meant by the ICH Q9 guideline? Which tools are available and how can they be used? How and where can I implement QRM in the quality management system? And how do I ensure that QRM is effectively integrated into my quality management system?

In the training we look at the root cause analysis to identify all possible causes that can lead to an error. We will practically work on performing a risk analysis according to the FMEA model, where we will further elaborate the analysis in various steps. In addition, we will discuss the risk ranking method. Through a combination of theoretical knowledge and practical application, we teach participants how to efficiently implement QRM.

There is also plenty of time for practical exercises in this classroom training. This gives you the opportunity to learn and possibly share knowledge in other ways.

GDP training ensures that the quality of pharmaceutical products is maintained throughout the supply chain, from the manufacturer to the end user. It focuses on proper distribution practices, storage conditions and transportation methods to prevent contamination, mix-ups and damage.

GDP training is essential to improve the skills required for efficient pharmaceutical distribution. Learn to implement Good Distribution Practice (GDP) standards to ensure regulatory compliance and maintain high quality assurance.

Quality managers, operations coordinators and transport managers

Experience

Basic knowledge of GDP guidelines required.

Please consult our training offer for the appropriate training.



Contents

• What and why QRM?
• Link to GDP guidelines
• ICH Q9 Quality Risk Management
• Risk assessment, Risk control, Risk communicatie en Risk review
• Implementation within the QMS with practical exercises
• Exam (80% minimum result) this training

Result

• Effective use of resources and less frustration
• Methodology to apply risk management
• Analyzing the risks in the business processes.
• Correctly assessing the risks.
• Continuous improvement of your processes (focus pharma)
• Certificate from our academy (after successfully completing the exam)