KURSUS
Quality Risk Management (QRM) in LifeScience
Gain methods and practical tools for systematic Quality Risk Management in life science. The course covers ICH Q9, GxP requirements and hands-on risk assessment across the entire product life cycle.
Kursusdetaljer
Roskilde
23. september 2026
Varighed: 2 dage
10.000,00 - 10.500,00 kr.
Priser er ekskl. moms
Engelsk
Quality Risk Management in practice
Quality Risk Management (QRM) is fundamentally about protecting patients from harm by systematically identifying, assessing and controlling risks related to products manufactured in the life science industry.
Quality Risk Management (QRM) is fundamentally about protecting patients from harm by systematically identifying, assessing and controlling risks related to products manufactured in the life science industry.
QRM is an essential part of a GxP company's overall Quality Management System, and is applied throughout the entire product life cycle – from development and production to operation and change management.
The course is based on both European and American guidelines, including ICH Q9 and Guidance to industry Q9 Quality Risk Management.
What you will work with during the course
- Principles of Quality Risk Management
- ICH Q9 (R1) and relevant GxP requirements
- Risk management across the product life cycle
- Identification and assessment of physical, chemical and biological hazards
- Selection and use of risk assessment methods and tools
- Typical challenges when implementing QRM in practice
Dissemination of contact information
Confirm
When registering for the course, your name, e-mail and telephone number will be passed on to Confirm. The contact information is used exclusively in connection withf your registration and for the course itself, but will not be used for marketing purposes.
This course is for you if you work with Quality Risk Management in life science
The course is relevant for you if you work with QRM in the life science industry and are involved in GxP activities – for example within management, QA, development, production or other technical functions – and want deeper insight and more practical tools for risk assessment.
The course is relevant for specialists as well as professionals working with quality, compliance and risk management.
Your outcome
After the course, you will be able to:
- Identify functions critical for patient safety, product quality and data integrity
- Facilitate and/or conduct risk assessments within your own area of responsibility
- Define key terms and principles within risk management
- explain the value and importance of effective risk management and risk assessment
- Work systematically with the different phases of risk management
- Identify, select and apply appropriate methods for hazard and risk assessment
- Identify common challenges related to implementing risk management
Advantages for your company:
Your company gains:
- An employee who understands the complexity of QRM
- stronger and more consistent risk assessments
- improved integration of risk management into daily work processes
- better prioritization of efforts towards areas with the highest value and impact
Both in the short and long term, this supports robust processes and regulatory compliance.
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Katharina Laungaard
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