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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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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.
Online
Biocompatibility

Deviation investigation and CAPA in the pharmaceutical industry – Course

This course focuses on root cause analysis and how to execute a successful CAPA management process from initial reporting to root cause analysis for the Pharmaceutical industry.
May 21
Stockholm, Sweden
CAPA

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.
Jun 11
Online
GLP

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.
May 12
Copenhagen, Denmark
Clinical evaluations, MDR, Post market, Risk

GIVIMP and GCCP for scientists – Course

The basics of the guidance documents Good in Vitro Method Practices (GIVIMP) and Good Cell Culture Practices (GCCP).
Online
GLP

GMP MasterClass course

Get a comprehensive review of GMP compliance requirements and tools to master application and interpretation of these requirements in pharmaceutical production.
QC-lab, Quality management and QA

Design, Development and Regulatory Compliance for Medical Devices and SaMD – Course

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.
ISO13485, IVDR, MDR, Regulatory Compliance

Validation of Analytical Procedures Made Easy – Course

What parameters are key to quality? How do we quickly and efficiently identify these parameters and decide on strategies to optimize quality? This webinar is focused on a “Faster, Better, Cheaper” methodology. Targeted to medical device and pharmaceutical professionals involved in meeting Design Control and Process Validation.
Online
Design Control, Statistics, Validation and Qualification

Usability for Medical Devices – Course

How do you know if the users think your device is “Easy to use”? Learn how to establish, implement and monitor a usability process.
Jun 24
Online
Usability

Cybersecurity in Medical Device Lifecycle – Course

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

Introduction to IVDR – Fundamentals of IVDR and CE-marking of IVDs – Course

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

Responsibilities of the PRRC – and methods to manage them – Course

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

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!
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?
May 25
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.
Online
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

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