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GBA Key2Compliance® solves all your training needs in terms of regulatory requirements, GMP, GXP and quality systems for pharmaceutical & medical device industry.
Below you can browse our upcoming trainings, both on-site in Northern Europe and online. Our network of experts cover a wide range of important and contemporary topics to meet your needs.

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QMSR – The FDA revision of 21 CFR 820 in relation to ISO 13485:2016
On January 31, 2024, the FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference, ISO 13485:2016.
The FDA will begin to enforce the QMSR requirements from February 2, 2026. Until then, manufacturers are required to comply with the QS regulation. Learn about the scope and impact of this decision.
Jul 4
Online
Quality management and QA
IVDR and requirements on the Quality Management System
- What are the requirements on legal manufacturers, to achieve CE-certification for in-vitro diagnostic devices?
- What will the NB need look for when auditing our Quality Management System?
- What is the responsibility of the PRRC, in relation to the QMS?
This training will give you the answers!
Sep 2
Online
In-vitro Diagnostics, Quality management and QA