Course overview

This advanced participative process validation training course is designed to ensure that you understand the current EU and FDA requirements for the design, execution, assessment and reporting of equipment qualification and process validation studies

You will learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Course Outline

During the two days the course will cover the following aspects:

• The Concept of Process Validation.
• Current Regulatory Expectations.
• The impact of ICH Q8, 9, 10, 11 and draft Q12.
• How to Gain Process Understanding (FDA Stage 1): Quality by Design.
• Facility Design and Qualification of Equipment and Utilities (FDA Stage 2.1).
• Process Validation/Process Performance Qualification (PV/PPQ) (FDA Stage 2.2).
• Continued/Ongoing Process Verification (FDA Stage 3).
• Tools That Enable Effective and Efficient Validation: Quality risk management. 
• Change Management.

Who Should Attend

This course is ideal for technical and managerial personnel responsible for facility/utility/equipment qualification and process validation.

• Quality assurance.
• Manufacturing.
• Engineering.
• Research and development.
• Quality control.