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. This course provides you with the tools you need 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, conducting 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 comply with international guidelines.
Complaint Handling and Recall Management
Be inspection-ready by establishing robust processes for handling complaints 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 organization.
Management Responsibility and Compliance with GMP
Lead with confidence – drive quality and compliance in a GMP environment
Strong GMP compliance requires strong and confident leaders. This course prepares 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 the need for manual review and pinpoint exactly what affects your quality system.
CMO Management and Technology Transfer in GxP
Solve key challenges faced by external partners with greater control
Do you work with external partners and need greater control and a structured technology transfer process to ensure quality, compliance, and patient safety? This course provides you with a practical framework for managing external partners.
GMP in Pharmaceutical Construction
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 on and reduce the risk of redesigns, delays, and compliance issues.
Fundamentals of Quality Risk Management
Get Hands-On Experience 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
Staying up to date is key to success in your life sciences organization
Gain documentation of your organization’s GMP knowledge, insight into current GMP trends, and the opportunity to share experiences within your organization.
Root Cause Analysis and CAPA|company
Become an expert in addressing problems and improving quality within your organization
Gain insight into the techniques behind Root Cause Analysis (RCA) and learn how your organization can plan and implement effective Corrective and Preventive Actions (CAPA) to ensure continuous quality improvement.