The previously announced quality training course on has been postponed due to illness, and new dates are February 7th-8th. You therefore still have the opportunity to register!
The course is designed for anyone who need to know quality standards and find their way in a regulatory landscape, as an entrepreneur, employee or manager, and whether you work in or for a start-up company or other organizations within life science.
Day 1 is a general introduction to quality and standards that apply to products within pharma, medical equipment and food. Day 2 focuses on the quality system (QMS) – what it is, when it is required, and what it means to work under such a system. Both days will contain practical examples, and arrangements will be made for questions and discussions.
Everyone who takes part receives a certificate of participation with a description of the course content.
You can choose whether you want to participate on one of the days or both, see below.
Wednesday 7th February 9:00-16:00:
Introduction to regulatory requirements and quality standards for pharma, medical devices and food industry
Thursday 8th February 9:00-16:00:
Introduction to Quality Management Systems – fit for purpose
Oslo Science Park, Gaustadalléen 21, Meeting room to be decided.
One day training course (Day 1 / Day 2): NOK 7.000, Day 1 + Day 2: NOK 12.000
Early bird rate Day 1+ Day 2: NOK 10.000 in total, by signing up December 15 at the latest.
Managers, entrepreneurs, employees, students, and anyone else who would like an introduction and overview of the respective topics.
The two days will be delivered as independent training courses. However, for participants with limited knowledge of regulatory requirements and quality standards, participation on day 1 is recommended to fully benefit from day 2.
Register with the QR code or follow this link:
Day 1: Introduction to regulatory requirements and quality standards for pharma, medical device and food industry
This is a general introduction to the regulatory environment you will meet in various types of positions within the life science area, both in industry and public institutions. To qualify for such positions, it is crucial to understand the terminology and be familiar with regulatory standards. We will look into why the standards have been developed, and how they add value to the end users and to society.
Definitions of the various types of products in life science will be presented: Drugs, medical devices and food / cosmetics. We will discuss the importance of accurate product classification in the development process, explore general regulatory requirements and quality standards, and delve into the specific requirements for food, medical equipment, and pharmaceuticals at various stages of product development. We will also provide tools and tips to navigate the regulatory landscape and find information effectively.
Day 2: Introduction to Quality Management Systems
Here we take a step further and provide participants with a foundation in Quality Management Systems (QMS) and the application in various industries. The documentation requirements for various product development stages will be discussed, comparing and contrasting the perspectives of the medical device and pharmaceutical industry. We will further explore the guiding principles for the development of a QMS as well as the purpose and scope of a QMS, empowering participants to appreciate its significance in achieving organizational excellence.
We will describe the essential components of QMS, and give the participants a flavour of the implications, challenges, and benefits of working within a QMS framework. We will also discuss how an electronic QMS (eQMS) software tool may aid the everyday efforts in achieving and maintaining regulatory compliance and customer satisfaction.
08:30-09:00: Registration and coffee / tea
09:00-09:30: Welcome and introductions
09:30-16:00: Lectures, group work and question and answer sessions. The information will be illustrated by real life examples.
Lunch will be served 12-13 each day. Coffee and refreshments will be served during breaks in the morning and afternoon sessions.
Main presenter: Astrid Hilde Myrset
Assisted by Jowita Sleboda, Cathrine Frydenlund and Jhansi Panga