Training course Quality Assurance

The life science industry in Norway is growing, and it is important for the industry to get hold of motivated employees with the right competence and understanding. SurViva is offering a training course to give students a good understanding related to the reasons why regulatory standards have been developed, and how they add value to the end users and to society. Only by understanding the overall objectives of regulatory and quality requirements, employees will be motivated to do their best to comply with the standards.

Training course: Introduction to regulatory requirements and quality standards in life science

 

As the title indicates, the training course is a general introduction to the regulatory environment new employees will meet in various types of jobs, both in industry and in public institutions in the life science area. For students applying for such jobs, it is crucial to understand the terminology, and be familiar with terms and standards to appear relevant.

The course will present definitions of different types of products in life science, i.e. what are the definitions of drugs, medical devices and food / cosmetics. To be able to classify products correctly is crucial for companies during product development, and for some types of products this is really challenging. The course will further describe regulatory requirements and quality standards in general terms and will specifically look into the regulatory requirements and the quality standards applicable during the various phases of product development for food, medical equipment and pharmaceuticals. The course will also point to the relevant regulatory bodies and give the students tools and tips on how to find relevant information at a later stage.

The course will further present the concepts of quality management systems, and on the similarities and differences in requirements between different types of regulations. We will aim to give the students background understanding why quality systems are useful, and how they help businesses deliver according to expectations from customers, patients and the society. Today quality systems are best managed by electronic tools, and the course will give the students insights in how such systems work, and how they help daily operations in a regulated environment. 

The lecturers will aim to illustrate the information by real life examples and we will do our best to make the training course both useful and fun for the participants.

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