Public courses

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

What parameters are key to quality? How do we quickly and efficiently identify these parameters and decide on strategies to optimize quality?

This training is an introduction to GMP requirements for both manufacturing of investigational ATMP and ATMP with a marketing authorisation.

Lär dig att förstå, navigera, tolka och tillämpa GMP enligt krav i både EU och USA, samt ICHs guidelines för kvalitetssystem och kvalitetsriskhantering.

Gain essential Good Manufacturing Practice (GMP) and Quality Management System (QMS) skills to succeed in regulated Life Science industries.

Vi går igenom verktyg för att på ett tydligt sätt kunna kommunicera ut till exempel krav och förväntningar i olika situationer. Dessa verktyg hjälper QA-personal att ses som positiva ledare som inspirerar i kvalitetsarbetet.

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

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.

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

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 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.