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The life science industry in Norway is growing, and it is important for industry to get hold of motivated employees with the right competence and understanding. The course also aims to give the students a good understanding related to the reasons why such 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.
The lecturers will aim to illustrate the information with real-life examples and will try to make the training course both useful and fun for the participants.
Tentative Program:
Monday 6 February, 09:00 - 12:00
1. Introduction:
- Regulatory requirements, why and what
- Quality, what and why
- Steps / phases in life science product development
2. ISO standards
- ISO thinking
- ISO standards relevant for Life Science
- Certification and CE marks
- Production equipment
3. Product development for Food
- Development Process
- Regulatory bodies
- Requirements & responsibilities
- Q&As
Tuesday 7 February, 09:00 - 12:00:
1. Introduction:
- Recap from Day 1
- Definitions of different types of products in Life science
- Medical Device – Classification
2. Design and Development of Medical Device
- Medical Device Regulations (MDR) in EU
- ISO13485
- The Design & Development Process
3. Pharmaceutical Drug Development
- Drug Development phases
- Regulatory requirements – GLP, GMP, “GxP”
- What is applicable for each phase?
- Working in Pharma – examples
- Q&As
Thursday 9 February, 09:00 - 12:00
1. Introduction:
- Recap from Day 1 and 2
- Differences and similarities Medical Device and Drug development
2. Quality Management System (QMS)
- QMS overview
- QMS elements
- Differences and similarities QMS Pharma vs Medical Device
- Q&As
3. Recap and Summary
- Food, Medical Device & Drug development
- Test
Lecturers:
Astrid Hilde Myrset, CEO and Consultant SurViva AS
Turid Koksvik Høysæter, Senior Consultant QA & eQMS SurViva AS
Cathrine Frydenlund, eQMS Consultant SurViva AS
Contact: