Public courses

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

Basic course in GLP – Good Laboratory Practice

Get the basic knowledge and understanding needed for working in a GLP environment. Learn to find your way in the OECD GLP and other relevant guidances.
Aug 26
Online
GLP

GMP Up-dates

Changes and updates within the GMP regulations in the EU, US as well as a presentation of trends in Warning Letters, 483 observations and Recalls.

Aug 27
Online
General

Risk Management according to ISO 14971:2019

Get a good insight and understanding of the key requirements for a risk management system in compliance with EU regulations.
Aug 28
Online
Risk

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

Basic Training in Biological evaluation of Medical Devices

Get fundamental knowledge to understand how and when a biological evaluation, according to ISO 10993-1, should be performed and avoid the most common pitfalls.
Sep 11
Mölndal-Gothenburg, Sweden
Biocompatibility

CAPA and root cause analysis, tools for an effective CAPA process

Review the key requirements for Corrective Action and Preventive Action (CAPA), explore common industry practices.
Sep 18
Online
CAPA, Quality management and QA

Environmental Monitoring in Pharmaceuticals & Biotechnology

Gain essential skills to identify contaminants, apply sampling methods, manage sample transportation, incubate samples, and interpret test results effectively in a microbiological laboratory.
Sep 23
- Sep 24, 2025
Copenhagen, Denmark

Sampling: How Much Is Enough?

This fast-paced webinar will cover the details of application of Sampling without the burden of statistical complexity.
Sep 23
Online
Statistics, Validation and Qualification

MDSAP – a global approach

Learn how to plan perform and report internal MDSAP audits as well as best practice and tools how to be prepared to undergo or perform MDSAP audits.
Sep 24
- Sep 25, 2025
Copenhagen, Denmark
Auditing/Inspection, Quality management and QA

Grundkurs i GMP och kvalitetssystem

Introduktion till de regelverk och riktlinjer som gäller vid tillverkning av läkemedel och medicintekniska produkter, dvs GMP och QSReg.
Sep 24
Online
General

Clinical Evaluation for Medical Devices

Get a good insight and practical guidance on the key steps of performing and how to fulfill the requirements of a Clinical Evaluation.
Sep 25
- Sep 26, 2025
Online
Clinical development

Strategic communication

Get tools for clear communication about e.g. requirements and expectations in different situations. Be seen as a positive leader that inspires quality work.
Oct 7
- Oct 8, 2025
Copenhagen, Denmark
General, Quality management and QA

Medical Device Postmarket Surveillance – PMS

Learn the key requirements and how to maintain an efficient PMS system in compliance with the EU and US Medical Device regulations.
Oct 8
Online
Post market, Regulatory Affairs

CGMP för kvalitetskontroll (QC) och analysarbete

Fördjupningskurs med specialinriktning mot krav på kemisk och mikrobiologisk kvalitetskontroll under utveckling (klinisk fas) och tillverkning av läkemedel.
Oct 9
Online
QC-lab

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