Program Overview

Program Overview

The University of Copenhagen offers a course titled "Cancelled Quality Assessment and Legislation - From Idea to Product" as part of its Continuing and Professional Education program. This course is designed to provide students with knowledge of various quality assessment systems, such as ISO (Standardization), GMO, and GMP (Good Manufacturing Practice), from invention to product release.

Course Content

The course covers key topics including intellectual property rights (IPR), regulations required for production, and the continuous need for quality assessments to ensure high production standards. Students will work on 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.

Learning Outcomes

By the end of this course, students will have demonstrated the following knowledge, skills, and competences:

• Knowledge: Reflect on the required legislation, such as GMO regulations and food production standards, including national requirements. Gain insight into Quality Assurance (QA) and Quality Control (QC), importance of GMP, and including their definitions and applications. Acquire theoretical knowledge of intellectual property rights (IPR). Understanding the importance of IPR.
• Skills: Be able to apply various quality control/assessment methods and evaluate when to use different methodologies and tools. Explore a range of tools and techniques for quality control. Be able to analyze production processes and apply relevant control actions, e.g., GMP and GMO regulations.
• Competences: Reflect on different forms of quality control/assessment and how these are used. Be able to take responsibility in work situations and collaborate with peers to make decisions on quality measures from idea to product. Comprehending the necessary regulations for production.

Teaching and Learning Methods

The course includes lectures, case studies, and a final report. Theoretical concepts, methods, and challenges from idea to product release are taught in lectures and through exercises. Students will suggest appropriate actions based on relevant legislation. Guest lectures from industry professionals will provide insights into the requirements from idea to production. Throughout the course, students will work in groups on case studies (supplied by industry where possible). The final report will require students to analyze a production case and demonstrate an understanding of key quality assessment systems and legislation.

Literature

Course literature is available on Absalon.

Recommended Prerequisites

To successfully participate in this course within the "Biosolutions" program, students are recommended to have the following competences:

• A Bachelor's degree in biotechnology or related fields.
• Basic knowledge of plant biology and bioprocessing.

Assessment

• Type of Assessment: Oral examination, 20 minutes.
• Type of Assessment Details: The oral exam will consist of a short pitch based on the case, followed by detailed questions and discussions of the curriculum.
• Examination Prerequisites: Hand in final report.
• Aid: All aids allowed.
• Marking Scale: 7-point grading scale.
• Censorship Form: No external censorship. Several internal examiners.
• Re-exam: Same as the ordinary exam. If the requirements are not met, the student needs to hand in a report 3 weeks before the re-exam.

Course Details

• Course Type: Single subject courses (day).
• Workload:
  • Lectures: 57 hours.
  • Preparation: 70 hours.
  • Practical exercises: 20 hours.
  • Project work: 50 hours.
  • Guidance: 8 hours.
  • Exam: 1 hour.
• Language: English.
• Course Number: NPLK25005U.
• ECTS: 7.5 ECTS.
• Programme Level: Full Degree Master.
• Duration: 1 block.
• Placement: Block 1.
• Schedule Group: C.
• Capacity: 40. The number of places might be reduced if you register in the late-registration period (BSc and MSc) or as a credit or single subject student.

Department and Faculty

• Contracting Department: Department of Plant and Environmental Sciences.
• Contracting Faculty: Faculty of Science.
• Course Coordinator: Kirsten Jørgensen.