Process Validation with Qualification

Attending this invaluable two-day event will give you the tools to fully understand and comply with current EU and FDA process validation guidelines and meet implementation challenges.

In today's pharmaceutical and biopharmaceutical industries, ensuring the reliability and efficiency of manufacturing processes is paramount. The need for rigorous process design, equipment qualification, and validation extends beyond mere compliance; it directly impacts product quality, patient safety, and regulatory adherence.

This comprehensive programme addresses these critical needs by taking a practical and analytical approach to process design, equipment, and utility qualification. It bridges the gap between product specifications and the meticulous verification required for equipment and processes at commercial scale.

Participants will delve into the foundational principles of Good Engineering Practice (GEP), essential for maintaining consistency and reliability throughout the manufacturing lifecycle. The course explores a range of advanced techniques, including Quality Risk Management (QRM), Design of Experiments (DoE), and statistical analysis. These methodologies are pivotal in optimising process qualification, verification, commissioning, and validation to achieve continual improvement and regulatory compliance.

Through expert guidance, attendees will learn how to apply these principles effectively, ensuring robust process design and validation strategies aligned with industry standards and best practices.