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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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Acceptance Sampling Plans: Inspection by Attributes

Get an understanding of the terminology and goals of acceptance sampling plans without delving deep into the statistical theory. Part 2.
Oct 22
Online
Statistics

Cybersecurity in Medical Device Lifecycle

How to have your Medical Devices compliant with the cybersecurity requirements: risk management, design, development, maintenance, and post-market surveillance.
Oct 13
Online
Computers/Software

Literature Search & Review for MDR Compliance – Practical Training

Learn how to effectively plan, perform, and document literature searches to meet MDR requirements, ensuring robust compliance and risk management. Through practical tips, case studies, and best practices, you will gain valuable insights that enhance the quality and efficiency of your literature review and State of The Art analysis throughout the entire device lifetime.
Online
Clinical evaluations, MDR, Post market, Risk

The IVDR challenges – do you have everything under control?

Online
IVD

ISO13485:2016 – from an auditing perspective

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

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.
Oct 21
Online
Statistics

Design of Experiments – DOE

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

Design, Development and Regulatory Compliance for Medical Devices and SaMD

Learn how to apply design controls to ensure regulatory compliance for both hardware and software medical devices using agile development principles. This course covers ISO 13485, IEC 62304, EU MDR, FDA, risk management, SaMD, AI, and cloud-based technologies.
Nov 25
- Nov 26, 2025
Copenhagen, Denmark
ISO13485, IVDR, MDR, Regulatory Compliance

Responsibilities of the PRRC – and methods to manage them

Get understanding of the responsibilities of the PRRC and how this can be defined within the organisation. Important also for CEO and top management.
Online
IVDR, MDR, Quality management and QA, Regulatory Affairs

Usability for Medical Devices

How do you know if the users think your device is “Easy to use”? Learn how to establish, implement and monitor a usability process.
Nov 11
Online
Usability

Are Your Data Normal or Not?

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?
Nov 18
Online
Statistics

Introduction to IVDR (746/2017) and CE-marking of In-Vitro Diagnostic devices

Learn about the IVDR and CE-marking of IVD medical devices. Understand the regulatory requirements for IVD medical devices. Understand the obligations under IVDR
Nov 18
Online
IVD, IVDR, Regulatory Compliance

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!
Biocompatibility

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

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.
Nov 4
- Nov 5, 2025
Online
Clinical development, Clinical investigations

Technical Documentation and risk classification, according to IVDR (746/2017)

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
Nov 27
Online
CE-marking, Documentation, IVD, IVDR, Risk

Medical Device Supplier Control and Outsourcing

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 19
- Nov 20, 2025
Copenhagen, Denmark
Quality management and QA

Sampling: How Much Is Enough?

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

Process validation – Medical Devices

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

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