Navigating Drug–Device Combination Products (CP’s)
Cross-functional development and lifecycle management of CPs: assessing risks and interfaces
Learn how drug and device components come together throughout development, approval, and lifecycle management. Focus on risks, interfaces, and practical cross-functional challenges (i.e., EDDOs), with clear examples from EU and US regulatory expectations.
Mastering GMP Inspections
Gain practical tools to prepare for, host, and follow up on regulatory GMP inspections
This course provides practical guidance on how to prepare your organisation, manage the inspection process, and respond effectively after the inspection. A key strength of the course is the combination of practical industry experience and direct regulatory insight from an experienced GMP Inspector from the Danish Medicines Agency.
Basic GMP
Understand GMP and learn how companies work with it in practice
This course, including evening activities and an overnight stay, provides you with a solid foundation in GMP. You will learn through case work, exercises, and a GMP game.
The course also gives you the opportunity to network with others who are new to life science.
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.
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.
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.
Basic GMP
Understand GMP and learn how companies work with it in practice
This course, including evening activities and an overnight stay, provides you with a solid foundation in GMP. You will learn through case work, exercises, and a GMP game.
The course also gives you the opportunity to network with others who are new to life science.