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GBA Key2Compliance® solves all your training needs in terms of regulatory requirements, GMP, GXP and quality systems for pharmaceutical & medical device industry.

Below you can browse our upcoming trainings, both on-site in Northern Europe and online. Our network of experts cover a wide range of important and contemporary topics to meet your needs. 

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How ISO13485 prepares your
IVDR Quality System for audits
and what it doesn't cover

Gain insights on how your compliance strategy can
ensure your products meet the new requirements.

May 27th 10.30-11.15 CET

Register today!

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GMP-krav på datoriserade system

Utbildning om de FDA och EU-regler och tolkningar som berör datoriserade och automatiserade system vid läkemedelstillverkning: 21 CFR 11 och EU GMP Annex 11
Apr 23
- Apr 24, 2025
Stockholm, Sweden
Computers/Software

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.
Apr 29
- Apr 30, 2025
Copenhagen, Denmark
Post market, Quality management and QA, Regulatory Affairs

CAPA and root cause analysis, tools for an effective CAPA process

Review the key requirements for Corrective Action and Preventive Action (CAPA), explore common industry practices.
May 6
Online
CAPA, Quality management and QA

Software Assurance and validation of software for QMS process

Learn the concepts of QMS software validation, how to assess risks related to QMS software and how to apply IQ, OQ and PQ to QMS software.
May 12
Online
Computers/Software, Validation and Qualification

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!
May 14
Mölndal-Gothenburg, Sweden
Biocompatibility

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.
May 15
Online
Change management, Risk

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.
May 19
Online
Computers/Software

What is Process Capability and How to Measure It?

Get a simple flow chart on methods to establish and maintain product and process capability through meaningful measures of quality.
May 26
Online
Process capability, Quality measures

Validation and qualification

Get in-depth knowledge of regulatory requirements regarding validation and qualification and their application in the pharmaceutical industry.

Jun 3
- Jun 4, 2025
Stockholm, Sweden
Validation and Qualification

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.
Jun 3
Online
Auditing/Inspection, Quality management and QA

Requirements to place Medical Device Software and Health Software on the market

Regulations and standards applicable to Medical Device Software: mobile apps, web apps, connected objects, and/or standalone software for diagnosis or planning.
Jun 11
- Jun 12, 2025
Copenhagen, Denmark
Computers/Software

Grundlæggende om GMP

En samlet og inspirerende gennemgang af, hvad GMP og kvalitetssystemer er, og hvorfor det er vigtigt i LifeScience – Pharmaceuticals and Medical Technology
Jun 12
Online
General, GMP

GMP MasterClass

Get a comprehensive review of GMP compliance requirements and tools to master application and interpretation of these requirements in pharmaceutical production.
Jun 17
- Jun 18, 2025
Copenhagen, Denmark
QC-lab, Quality management and QA

IVDR and requirements on the Quality Management System

- What are the requirements on legal manufacturers, to achieve CE-certification for in-vitro diagnostic devices? - What will the NB need look for when auditing our Quality Management System? - What is the responsibility of the PRRC, in relation to the QMS? This training will give you the answers!
Jun 18
Online
In-vitro Diagnostics, Quality management and QA

Auditor/Lead Auditor – Läkemedel och medicinteknik

Denna specialanpassade utbildning ger dig de verktyg och färdigheter som krävs som Auditor eller Lead auditor inom läkemedels- och medicinteknisk industri.
Jun 24
- Jun 26, 2025
Stockholm, Sweden
Auditing/Inspection, Validation and Qualification

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