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GBA Key2Compliance solves all your training needs in terms of regulatory requirements, GMP, GXP and quality systems. Knowledge of these requirements is an important key to developing, manufacturing and distributing safe and effective drugs and medical devices. Training from GBA Key2Compliance makes the knowledge easily accessible, applicable and makes it clear how the regulatory requirements affect your business.

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ISO13485:2016 – from an auditing perspective – Course

Get a full understanding of the requirements ISO13485:2016 place on your Quality Management System, as well as the solutions recommended in the 13485 Handbook.
Online
Auditing/Inspection, Quality management and QA

Advanced Training in Biological Evaluation of Medical Devices

Learn how and when a biological evaluation, according to ISO 10993-1, should be performed. Understand the evaluation requirements and avoid common pitfalls!
Dec 8
- Dec 9, 2026
Mölndal-Gothenburg, Sweden
Biocompatibility

Design of Experiments – DOE – Course

What parameters are key to quality? How do we quickly and efficiently identify these parameters and decide on strategies to optimize quality?
Online
Design Control, Statistics, Validation and Qualification

CE-marking – Risk classification of IVDs & Technical Documentation – Course

Learn about the new rule-based risk classification. Understand how the risk classification impacts on the conformity assessment route Learn about the general safety and performance requirements and how to demonstrate compliance Understand the structure and content of the Technical Documentation Understand how design changes to the product design impact on the technical documentation
Online
CE-marking, Documentation, IVD, IVDR, Risk

Process validation – Medical Devices – Course

Gain increased knowledge about both the preparations required and the main parts that are included in process validation for medical devices.
Oct 22
Online
Validation, Validation and Qualification

Are Your Data Normal or Not? – Course

What is “Normal” data? How do you know if your data are Normal? What do you do if your data are not Normal? Why would you care?
Online
Statistics

IVDR Performance Evaluation, Risk Management, PMS and PMPF – Course

Learn about the new rule-based risk classification. Understand how the risk classification impacts on the conformity assessment route Learn about the general safety and performance requirements and how to demonstrate compliance Understand the structure and content of the Technical Documentation Understand how design changes to the product design impact on the technical documentation
Online
CE-marking, IVDR, Post market, Risk

Medical Device Supplier Control and Outsourcing – Course

Get tools and examples of best practice and learn how use the ‘Plan – Do – Check - Act approach’ to control and verify the performance of your suppliers.
Nov 17
- Nov 18, 2026
Copenhagen, Denmark
Quality management and QA

Becoming a Regulatory Affairs Manager for Medical Devices – Course

Get the knowledge and skills needed to lead the RA function at a medical device organization. Interpret and apply MDR, IVDR, and ISO 13485 effectively.
Oct 6
- Oct 7, 2026
Copenhagen, Denmark
Post market, Quality management and QA, Regulatory Affairs

ISO 14155:2020 – Good Clinical Practice for Medical Devices (GCP) – Course

A practical approach to medical device clinical investigations according to ISO14155. How to plan, perform and document. Examples on what to focus on and which types of investigations to apply when, during your device development.
Online
Clinical development, Clinical investigations

IVDR training series: Mastering IVDR Compliance

Training series contains 3 parts, half a day each.
  1. Intro to IVDR -Fundamentals of the IVDR and CE-marking of IVDs
  2. CE-marking - Risk classification of IVDs and Technical Documentation
  3. IVDR Performance Evaluation, Risk Management, PMS and PMPF
- Feb 5, 2026
Online
CE-marking, IVD, IVDR, Post market, Risk

Sterilization of Medical Devices Course

In-depth training on assessing suitability, adequacy and effectiveness of medical device sterilization methods.
Oct 1
- Oct 7, 2026
Copenhagen, Denmark
Auditing/Inspection, Bioburden, ISO 11737, Sterilization, Validation

Sampling: How Much Is Enough? – Course

This fast-paced webinar will cover the details of application of Sampling without the burden of statistical complexity.
Dec 3
Online
Statistics, Validation and Qualification

Avvikelseutredning och CAPA i läkemedelsindustrin – Kurs

Lär dig om CAPA och alla steg som en avvikelse passerar: initiering, utredning, design av åtgärder, effektuppföljning och rapportskrivande. Undvik fällorna!
CAPA

Acceptance Sampling Plans: Inspection by Attributes – Course

Get an understanding of the terminology and goals of acceptance sampling plans without delving deep into the statistical theory. Part 2.
Online
Statistics

IVDR in a nutshell – Risk Management course

What is required to demonstrate compliance to the IVDR regarding Risk Management? How do I perform risk analysis, and estimate probability and severity? How to deal with legacy devices? This training will give you the answers!
Online
In-vitro Diagnostics, Risk

Change Management for Medical Devices – Course

How to apply a risk-based approach when managing changes to your medical device to ensure compliance, maintain quality, and ultimately protect patient safety.
Oct 13
Online
Change management, Risk

Acceptance Sampling Plans: Inspection by Variables

Get an understanding of the terminology and goals of acceptance sampling plans without delving deep into the statistical theory.
Online
Statistics

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