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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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Change Management for Medical Devices – Course

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.
Online
Statistics

IVDR in a nutshell – Technical Documentation course

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

Course in Quality Risk Management and Root Cause Investigations

An overview of QRM and RCI and the respective regulatory expectations. Common tools and methods for the Pharma and Medical Device industry.
Dec 1
- Dec 3, 2026
Copenhagen, Denmark
QRM, Risk

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 5
Kolding, Denmark
Cleaning in place, Sterilization

GMP for Clinical Trial Material (CTM) – Course

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 – Course

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

Training: Use of AI Power in your Medical Device lifecycle

Learn how to accelerate medical device development, approval, and post-market activities with compliant use of LLMs.
Dec 9
- Dec 10, 2026
Online
AI, Computers/Software, Regulatory Compliance

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.
Feb 11
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.
CAPA

AI Medical Device Regulatory Strategy and Clinical Evaluation Training

This practical masterclass helps AI start-ups, medical device manufacturers and development teams determine when software qualifies as a medical device, plan EU market access, build proportionate quality and technical documentation, and define the clinical evidence needed to support intended purpose, claims, safety, performance and clinical benefit.
Nov 26
Online
AI, Computers/Software, Regulatory Compliance

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.
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.
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.
GMP, 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.
Online
Usability

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