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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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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

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

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

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

IVDR Performance Evaluation, Risk Management, incl Post-Market Surveillance and PMPF

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
Dec 9
Online
CE-marking, IVDR, Post market, 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

Becoming a Regulatory Affairs Manager for Medical Devices

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.
Post market, Quality management and QA, Regulatory Affairs

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.
Online
Clinical development, Clinical investigations

IVDR training series

Training series contains 3 parts, half a day each.
  1. Fundamentals of the IVDR and CE-marking of IVDs
  2. IVDR – key elements of the risk classification and technical documentation for the CE-marking process.
  3. IVDR Compliance: Demonstrating Performance and Safety for IVD Devices
Nov 18
- Dec 9, 2025
Online
IVD, IVDR

Sterilization of Medical Devices

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

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

Avvikelseutredning och CAPA i läkemedelsindustrin

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

IVDR in a nutshell – Risk Management

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

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

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.
Online
Statistics

IVDR in a nutshell – Technical Documentation

What is required from your technical documentation to achieve CE-certificate for your in-vitro diagnostic devices? This training will give you the answers!
Online
In-vitro Diagnostics

Alfa Laval Live Cleaning-in-Place Experience & Site Tour

Experience Cleaning-in-Place (CIP) technology in action, incl. sustainability-focused cleaning processes, real-life trials, with experts in cleaning validation.
Nov 7
Kolding, Denmark
cleaning in place, Sterilization

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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