Our Courses

Get understanding of the responsibilities of the PRRC and how this can be defined within the organisation. Important also for CEO and top management.

Get tools and examples of best practice and learn how use the ‘Plan – Do – Check - Act approach’ to control and verify the performance of your suppliers.

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 full understanding of the requirements ISO13485:2016 place on your Quality Management System, as well as the solutions recommended in the 13485 Handbook.

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.

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

Förstå de centrala krav som måste vara uppfyllda för att utforma och förvalta ett kvalitetsledningssystem enligt regelverken i EU och USA.

Develop the skills and techniques to conduct more effective investigations of quality incidents and identify ways to reduce the likelihood of recurrence.

MDR Audit Readiness – how to assess if your ISO 13485:2016 Quality Management System is MDR compliant

Learn the key requirements of a quality management system in compliance with EU and US Medical Device regulations and how to implement them in your quality system.

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

- 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 equipped and prepared to lead the QA/RA function in a medical device organization and learn the latest about medical device regulations and quality system standards.

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.

Vi hjälper dig att utvecklas som individ och som QA-ledare! Du får en forskningsbaserad modell för hur du kan utvecklas som ledare och skapa en positiv trygg kultur där medarbetarna uppfattas som positiva ambassadörer för kvalitetsarbete.

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.

Knowledge management is considered a key enabler of a modern pharmaceutical quality system. This workshop provides participants practical ways of how training and learning contribute to a robust knowledge management program.