Public courses

Få fördjupade kunskaper om de regulatoriska kraven kring validering och kvalificering vid läkemedelstillverkning och hur de appliceras.

This tailor made training gives you the tools and skills required as Auditor or Lead Auditor in the Pharmaceutical and Medical Device industry.

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.

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.

Learn how valid statistical techniques contribute to Process Validation efforts. Best practices for quality systems in industry.

Learn how valid statistical techniques contribute to Process Validation efforts. Best practices for quality systems in industry.

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.

Learn how to plan perform and report internal MDSAP audits as well as best practice and tools how to be prepared to undergo or perform MDSAP audits.

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.

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

Learn about the IEC 62304 requirements throughout the lifecycle of software, how it integrates with Risk Management activities and the need for documentation.

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.