Public courses

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

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

This webinar will provide a valid statistical procedure that is so simple, you won’t even know that you are applying statistics -- all the time.

Denna specialanpassade utbildning ger dig de verktyg och färdigheter som krävs som Auditor eller Lead auditor inom läkemedels- och medicinteknisk industri.

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.

Varför det är viktigt och värdeskapande att arbeta på ett riskbaserat sätt och hur detta används inom läkemedelsindustrin. Viktiga grundbegrepp och verktyg.

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.

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.

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

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

Learn how and when a biological evaluation, according to ISO 10993-1, should be performed. Understand the evaluation requirements and avoid common pitfalls!

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

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.