Design and Implementation of Quality Management System (QMS)

It is a regulatory requirement to have a QMS (Quality Management Systems) in place before initiating clinical trials. A well-designed QMS ensures clarity, improves efficiency and applies risk management to ensure safe and effective products.

In this course you will get an overview of the regulatory requirements for a QMS. You will learn about the requirements for both pharmaceuticals (drugs and biologics), medical devices and combination products.

You will see examples of a QMS for both a small early-stage biotech/medtech company and a large multi-product global company involved in both clinical trials and marketed products.

Furthermore, we will discuss how to write SOPs (Standard Operating Procedures) that are compliant and user-friendly.

Finally, you will learn what to consider when selecting the IT system that is best suited for your QMS and your organisation.

The course language is English.

At the course you will meet:
Erik Steffensen, Managing Partner and Principal Consultant, Spot-on Pharma Consulting