Quality Assessment and Legislation - From Idea to Product

From invention to product release, several regulations and quality systems must be implemented and adhered to. This course provides students with knowledge of various quality assessment systems, such as ISO (Standardization), GMO, and GMP (Good Manufacturing Practice).

Key topics include intellectual property rights (IPR), regulations required for production, and the continuous need for quality assessments to ensure high production standards, continously assessing quality and compliance with international requirements.

Students will work examples from production and cases where they need to analyze how to establish and implement quality systems. They will also explore the global differences in standards and regulations..

In the course, students will gain insights into intellectual property rights and understand the legislative requirements across different regions.

Examples of course areas from idea to production include:

• The IPR area and landscape.
• Regulatory Frameworks: Legal and regulatory frameworks at the international, national, and local levels, how to interpret and apply these.
• Production requirements, including GMO approval and environmental concerns.
• Quality control tools and techniques , the principles of quality control and its significance across industries.
• Quality Assurance Methodologies: Presentation of  various quality assurance models, such as ISO standards, and learn how these are implemented to improve processes and outputs.
• Product/Service Standards: Definition, measuremets, and maintain product and service standards that align with industry regulations and meet customer expectations and safety.
• Documentation and Reporting.
• Introduction to the legal framework for the green deal on products.