Stability Studies and Documentation
Gain practical insights into designing, conducting, and documenting stability studies
Understand the requirements for designing stability studies, performing stability testing, and preparing stability documentation.
In collaboration with life science experts and the Danish Medicines Agency, we cover everything from initial development to ongoing stability studies, ensuring that you meet international guidelines.
Complaint Handling and Recall Management
Be inspection-ready by establishing robust processes for complaint handling and product recalls
Learn how to set up effective processes for investigating customer complaints and managing product recalls.
Gain insight into regulatory requirements and practical examples to enhance compliance and inspection readiness in your organisation.
Management Responsibility and Compliance within GMP
Lead with confidence – drive quality and compliance in a GMP world
Strong GMP compliance requires strong and confident leaders. This course equips you to step confidently into your GMP leadership role, gain an overview of your responsibilities, and stay in control every day.
PQS Compliance with New Requirements
Stay ahead of new regulatory requirements
Learn a practical and reliable process for monitoring and implementing new requirements in your PQS. Discover how AI can reduce manual review and highlight exactly what impacts your quality system.
CMO Management and Technology Transfer in GxP
Solve key external partners challenges with more control
Do you work with external partnership and need stronger control and a structured technology transfer to secure quality, compliance and patient safety? This course gives you a practical framework for managing external partners.
GMP in Pharma Constructions
Design pharmaceutical facilities and areas with GMP in mind from the very first design step
Learn the essential regulatory knowledge you need to design or renovate areas within pharmaceutical facilities. Understand key design requirements early and reduce the risk of redesign, delays, and compliance issues.
Fra compliance til kvalitetskultur|virksomhed
Når kvalitet bliver mere end compliance
Lær at omsætte GMP, så I ikke kun følger kravene, men også bidrager aktivt til en stærk kvalitetskultur, der styrker både patientsikkerhed, data og samarbejde.
Lær af egne cases og få fælles retning|virksomhed
Få en faciliteret workshop, hvor I afsætter fælles tid til at forstå og lære af egne cases
Har I afvigelser, SOP’er, auditfindings, samarbejdsudfordringer eller andre produktionscases, som kalder på tid sammen til at opnå indsigt og vigtig læring?
Kvalificering og validering – fra krav til test|virksomhed
Opnå ”the basics” indenfor kvalificering og validering
Få styr på krav til kvalificering og validering, når nyt udstyr eller nye processer skal bruges i lægemiddelfremstilling – og lær at sikre sporbarhed fra krav til test.
GMP – fra lovkrav til hverdag|virksomhed
Forstå lovkravene i din hverdag
Forstår I, hvorfor I gør, som I gør?
Og ved I, hvor stor en forskel den enkeltes indsats gør for det færdige lægemiddel?