Public courses

On January 31, 2024, the FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference, ISO 13485:2016. The FDA will begin to enforce the QMSR requirements from February 2, 2026. Until then, manufacturers are required to comply with the QS regulation. Learn about the scope and impact of this decision.

Introduktion till de regelverk och riktlinjer som gäller vid tillverkning av läkemedel och medicintekniska produkter, dvs GMP och QSReg.

Get a good insight and understanding of the key requirements for a risk management system in compliance with EU regulations.

In-depth training on assessing suitability, adequacy and effectiveness of medical device sterilization methods.

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.

Get a comprehensive review of GMP compliance requirements and tools to master application and interpretation of these requirements in pharmaceutical production.

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.

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

How to apply a risk-based approach when managing changes to your medical device to ensure compliance, maintain quality, and ultimately protect patient safety.

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

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

How do you know you have quality if you cannot reliably measure what you are doing? Are you afraid of complex statistical concepts and procedures? These two webinars will help you to evaluate your measurement systems, diagnose problems, and fix them. How is it “made easy”?

This second webinar will focus on Attribute Measurement Systems – that is, the subjective inspection of items to see if they satisfy requirements. Since humans are the “gauges”, attribute measurement systems can have high variation. How do you evaluate this human judgement and how can you improve their results? And how is it “made easy”?

A course to understand how to design and develop medical devices to ensure their safe and effective use.

Gain increased knowledge about both the preparations required and the main parts that are included in process validation for medical devices.