Process Validation

The course starts with an introduction to modern process validation and emphasizes its importance. You will learn about Quality Risk Management and Process Design using Quality by Design principles. We focus on establishing process understanding and using Design of Experiments (DoE) and Process Analytical Technology (PAT) for process design. You will understand how DoE is used to identify critical process parameters and design a robust process space.

The course also introduces science- and risk-based facility and equipment qualification. We provide an example of how Novo Nordisk implemented their process validation lifecycle with a focus on facility design and qualification. Discussions on regulatory observations, traditional, continuous, and hybrid validation methods give you insights into best practices. We cover process validation readiness, evaluation, and presentation of validation results, focusing on Ongoing Process Verification for both new and existing products.

An expert from Lundbeck will share practical experiences about their OPV program. Statistical tools for process validation and monitoring will be reviewed, and you will learn how to use these tools to ensure that the process remains in control. Finally, we look ahead to the future of process validation with fully automated processes.

Upon completing this course, you will be able to apply a science- and risk-based approach to process validation, develop and implement control strategies, and ensure that your processes comply with regulatory requirements. This course combines theory, practical case studies, and experience sharing to equip you with the necessary tools for effective process validation.

The course language is English.

At this course you will meet:

Line Lundsberg, Managing Consultant, NNE
Andreas Houmann, QMS Specialist, Novo Nordisk A/S
Michael Lauridsen, Senior Specialist, Lundbeck A/S