Course manager

Majbrit Wigø Madsen

Semester schedule

Autumn (13-week period)

ECTS

5

Language of instruction

English

Course type

Obligatory

Qualifications

Competencies corresponding to participation in the courses Project 1, 2, and 3 are recommended.

It is an advantage to have chemical and microbiological insight and understanding of unit operations.

Objectives

To enable the student to understand how companies in the biotechnological industry implement, build, maintain, operate and evaluate Quality Management System (QMS), including insight into Good Manufacturing Practices (GMP) and regulatory requirements for companies.

Content

• Certification and accreditation including international and national certification and accreditation bodies.
• Relevant legislation in relation to companies with focus on the EU GMP & Own Check Programme, including roles and responsibilities.
• Requirements and recommendations for implementing and structure of Quality Management Systems(QMS)
• Use of risk assessments as part of QMS with a focus on HACCP
• Application af QMS in practice via cases where different situations that may arise are simulated. For example, handling changes, deviations, audits, qualifications and validations.
• Understanding of relevant concepts and definitions within QMS

Learning targets

The student must gain the ability to idndependently understand the content and the need for implementation af QMS in companies.

After completing  the course, the student is expected to be able to:

Knowledge

• Understand and explain the structure and use of Quality Management Systems (QMS)
• Understand and explain regulatory requirements for companies
• Understand and explain Good Manufacturing Practies(GMP)
• Understand and explain the use of risk assesments

Skills

• Explain the structure and operation of quality management systems (QMS) as well as terms, tools and definitions.
• Engage in dialogue about why implementing Quality Management Systems(QMS) can be beneficial for companies by understanding the complexity.
• Demonstrate and explain how different situations in Quality Management Systems(QMS) can be handled, such as changes, deviations, audits, qualifications and validations.
• Demonstrate knowledge of selected ISO standards and ICH guidelines and explain how the requirements in these can be complied with.
• Explain public authority issues in relation to companies, including Good Manufacturing Practice(GMP) and Own Check Programme.
• Explain the difference between legislation, standards, guidelines and give concrete examples related to companies.
• Demonstrate and explain the use of HACCP

Competences

• Be able to present how to handle different situations in Quality Management Systems(QMS)
• Be able to describe the construction, implementation and operation of Quality Management Systems (QMS)
• Be able to put into perspectie the implementation and use of Quality Management Systems(QMS) according to specific companies.
• Be able to put GMP into perspective according to specific companies.

Teaching method

Classroom teaching, group work and case presentations of companies and students, respectively.

Qualifications for examination participation

• Participation in all mandatory teaching activities.
• Everything is carried out and handed in according to guidelines specified by the course manager.

 

Examination and aids

Oral examination. No aids.

Duration of the test: 30 minutes.

Marking 

Internal

Grading

The 7-point grading scale