Validation of IT Systems
Understand and apply current standards for IT validation
Learn how to manage IT system validation and ensure data integrity and compliance. The course provides you with the tools needed to understand requirements, apply best practices, and strategically plan and execute IT validation activities.
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.
Quality Risk Management Fundamentals
Get hands-on with Quality Risk Management
Gain insight into Quality Risk Management (ICH Q9), understand its core principles, and learn how to apply them in practice.
Annual GMP|company
Updating is key to success in your life science organisation
Get documentation of maintained GMP knowledge, insight into current GMP trends, and the opportunity to exchange experience within your organisation.
Root Cause Analysis and CAPA|company
Become an expert in handling problems and improving quality within your organisation
Gain insight into the techniques behind Root Cause Analysis (RCA) and learn how your organisation can plan and implement effective Corrective and Preventive Actions (CAPA) to ensure continuous quality improvement.