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.
From Compliance to a Culture of Quality|Company
When Quality Goes Beyond Compliance
Learn how to implement GMP so that you not only meet the requirements but also actively contribute to a strong culture of quality that enhances patient safety, data integrity, and collaboration.
Learn from Your Own Cases and Establish a Shared Direction|Company
Join a facilitated workshop where you’ll set aside time together to understand and learn from your own cases
Do you have deviations, SOPs, audit findings, collaboration challenges, or other production-related issues that call for time spent together to gain insights and important lessons?
Qualification and Validation – From Requirements to Testing | Company
Master the basics of qualification and validation
Understand the requirements for qualification and validation when new equipment or processes are to be used in pharmaceutical manufacturing—and learn how to ensure traceability from requirements to testing.
GMP – From Legal Requirements to Everyday Practice | Business
Understand the legal requirements in your daily work
Do you understand why you do what you do?
And do you know how much of a difference each person’s efforts make to the final drug?