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 its process validation lifecycle, with a focus on facility design and qualification. Discussions on regulatory observations and traditional, continuous, and hybrid validation methods provide you with 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 from its 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 spans three days with an overnight stay, which provides time and space for reflection, immersion, and networking across participants—and thereby significantly enhances your overall learning outcomes.

Your benefits

• You will gain in-depth knowledge of modern process validation techniques and standards, enabling you to ensure high product quality.
• You will be introduced to Design of Experiments and statistical tools to identify and control critical process parameters.
• You will obtain insights into both EU and FDA requirements, preparing you to ensure compliance with international standards.

Your company's benefits

• Your employee will help improve regulatory compliance and reduce the risk of supply issues and production errors.
• Your employee will be able to implement an effective process validation methodology, ensuring that the company’s products are robust and consistently meet quality requirements.
• Your employee will be introduced to advanced statistical tools and quality management methods, potentially leading to more efficient production and long-term savings.