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.

Course program

Search among all our courses

Date range

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.

Mar 25

Online

Statistics

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 Variables

Get an understanding of the terminology and goals of acceptance sampling plans without delving deep into the statistical theory.

Mar 24

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.

Kolding, Denmark

cleaning in place, Sterilization

GMP for Clinical Trial Material (CTM)

Requirements you have to consider for manufacturing of CTM (Clinical Trial material) and how it differs over the phases I – III. - Review of recent changes.

Online

Clinical development, General, Quality management and QA

Environmental Monitoring in Pharmaceuticals & Biotechnology

Gain essential skills to identify contaminants, apply sampling methods, manage sample transportation, incubate samples, and interpret test results effectively in a microbiological laboratory.

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.

Apr 14

- Apr 16, 2026

Online

Biocompatibility

Deviation investigation and CAPA in the pharmaceutical industry

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.

Mar 26

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.

Online

Clinical evaluations, MDR, Post market, Risk

GIVIMP and GCCP for scientists

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

Online

GLP

GMP MasterClass

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

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

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.

Mar 4

Online

Design Control, Statistics, Validation and Qualification

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.

Mar 12

Online

Usability

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.

Mar 26

Online

Computers/Software