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.

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.

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

- 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!

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.

Review the key requirements for Corrective Action and Preventive Action (CAPA), explore common industry practices.

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

This fast-paced webinar will cover the details of application of Sampling without the burden of statistical complexity.

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 practical guidance on the key steps of performing and how to fulfill the requirements of a Clinical Evaluation.

Get tools for clear communication about e.g. requirements and expectations in different situations. Be seen as a positive leader that inspires quality work.

Learn the key requirements and how to maintain an efficient PMS system in compliance with the EU and US Medical Device regulations.

Fördjupningskurs med specialinriktning mot krav på kemisk och mikrobiologisk kvalitetskontroll under utveckling (klinisk fas) och tillverkning av läkemedel.