Audience:

Entrepreneurs, managers, employees, students, and anyone else that would like an introduction to and overview of the 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.

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 relevant for the life science area, both in industry and public institutions. To operate in this environment, 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 how they may vary with the business area, 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.

Programme both days:

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.

Lecturers:

Main presenter: Astrid Hilde Myrset

Assisted by Jowita Sleboda, Cathrine Frydenlund and Jhansi Panga 

Questions? Send to post@surviva.no