Introduction to this course: 

This course builds on the foundation laid in ‘Introduction to system validation and qualification’, diving deeper into the key phases of system validation and qualification. It covers system assessment and planning, URS, functional and design specifications, as well as IQ, OQ, and PQ.

Who should attend: 

This course is ideal for pharmaceutical professionals involved in product development and quality assurance, regulatory affairs specialists, validation and qualification engineers, and quality control personnel seeking advanced knowledge in system validation and qualification.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Identify the stages of system validation and qualification, including IQ, OQ, and PQ.

• Explain the principles behind the V-model and its application in risk assessment.

What will I gain: 

Participants will gain a solid understanding of the science and risk-based approach to process validation, from information and knowledge in product development activities to defining a control strategy for the manufacturing process.

Prerequisites: 

Completing the introductory course on system validation and qualification or a fundamental understanding of validation and qualification processes in the pharmaceutical industry is recommended.

Additional information: 

Course duration: 00:27:47

Course code/version (effective date): L-122/v1.0 (16/05/2023)