Our Courses

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.

Browse Courses

Course program

Search among all our courses

Select Filters
Type Of Course
Type Of Course
Language
Language
Industry
Industry
Location
Location
Subject
Subject
Type Of Course
Type Of Course
Language
Language
Industry
Industry
Location
Location
Subject
Subject

Date range

Date Filters Courses
Reset filters

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

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

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

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

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.
Jan 27
Online
Risk

Introduction to Risk-based thinking and Quality Risk Management

What is risk? How does an organization identify and reduce it? This course provide a working knowledge and skills of the concepts and tools used in managing risk with applications to pharma and biopharma activities.
Nov 24
- Nov 26, 2025
Online
Risk

FMEA Without Tears

This webinar provides a process to conduct FMEA and assess risk in an efficient way where everyone can agree on the results.
Online
Risk

Kvalitetsriskhantering inom läkemedelsindustrin

Varför det är viktigt och värdeskapande att arbeta på ett riskbaserat sätt och hur detta används inom läkemedelsindustrin. Viktiga grundbegrepp och verktyg.
General, Risk

EN ISO14971:2019 – Risk management – in relation to MDR and ISO13485

A guidance on how to implement the requirements of EN ISO 14971:2019 in your QMS. Understand its importance and relation to MDR and ISO 13485.
Online
Risk

Search

Search