Introduction to Quality Management Systems

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 aims to give the students a good understanding related to the reasons why Quality Management Systems are important and how they add value to the end users and to society. 

Time and place: –, Online

Register here

 

Registration deadline: 23 October 2023

 

This online workshop aims to equip participants with a solid foundation in Quality Management Systems (QMS) and their application within the context of various industries. By the end of the training, participants will have achieved the following learning outcomes:

  1. Terminology and Standards: Participants will gain a fundamental understanding of key quality terms and concepts, including ISO standards and pharmaceutical regulations, enabling them to navigate the intricacies of quality assurance effectively.

  2. Principles of QMS: Attendees will delve into the guiding principles that underpin Quality Management Systems, comparing and contrasting the perspectives of ISO and the pharmaceutical sector.

  3. Purpose and Scope of QMS: A clear comprehension of the purpose and scope of a Quality Management System will be attained, empowering participants to appreciate its significance in achieving organizational excellence.

  4. Components of QMS: Knowledge of the essential elements constituting a QMS will be acquired, covering areas such as quality policies, procedures, modules, and standard operating procedures (SOPs).

  5. Working under a QMS: Attendees will explore the implications and benefits of operating within a QMS framework, recognizing how it contributes to enhanced effectiveness and efficiency.

  6. eQMS Understanding: A comprehensive understanding of electronic Quality Management Systems (eQMS) will be developed, including practical insights into their functioning and application.

The training schedule is structured across three days, focusing on different aspects of QMS implementation:

Day 1 09:00-12:00: Participants will embark on an exploration of foundational quality concepts, ISO standards, and the interplay between Good Manufacturing Practice and QMS, as well as gaining insights into when quality management systems are essential in product development for food, pharmaceuticals, and medical devices.

Day 2 09:00-12:00: Building on Day 1, participants will delve deeper into the purpose and scope of QMS, understanding its context within an organization and its role in shaping a quality-driven culture. Key components, such as quality policies, manuals, SOPs, and effective document management, will be thoroughly covered, along with addressing critical areas like management review, deviation handling, risk management, and internal audits.

Day 3 09:00-12:00: The final day will recap the highlights of the previous days and address questions. Participants will examine the distinctions and parallels between medical device and drug development. The realm of electronic Quality Management Systems (eQMS) will be explored, supplemented by practical examples of operating within such systems. The training will conclude with a comprehensive recap of key insights and a dedicated Q&A session.

Upon completion of the program, participants will be well-equipped to navigate the complexities of Quality Management Systems, integrate their knowledge into practical scenarios, and contribute effectively to maintaining and enhancing product and process quality within their respective industries.

 

Lecturers:

Astrid Hilde Myrset, CEO and Consultant SurViva AS

Jowita Sleboda Consultant QA SurViva AS

Cathrine Frydenlund, eQMS Consultant SurViva AS

 

Contact:

Rosalie Zwiggelaar

Published Aug. 17, 2023 2:10 PM - Last modified Oct. 23, 2023 3:58 PM
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