Registration deadline: 3 September
The life science industry in Norway is expanding, highlighting the need for motivated employees with the right skills and comprehension. Our course aims to provide students with a solid grasp of why industry standards are developed and how they benefit end-users and society. Understanding the overarching objectives of regulatory and quality requirements is key to motivating employees to adhere to these standards diligently.
This course offers a broad introduction to the regulatory landscape students will encounter across various roles in both industry and public institutions within the life science sector. Familiarizing oneself with industry terminology and standards is crucial for students seeking employment in these fields to demonstrate relevance and competency.
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:
Tuesday 10 September, 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
Wednesday 11 September, 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 12 September, 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
Contact:
Rosalie Zwiggelaar, Research School coordinator