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.
Who Should Attend!
- This course is ideal for technical and managerial personnel responsible for facility/utility/equipment qualification and process validation.
- Quality assurance & Quality control
- Manufacturing · Engineering
- Research and development
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
- Change Management
- 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
Learning Outcomes By the end of this course
- Understand regulatory requirements in EU, US and internationally for process validation, qualification & analytical methods.
- Understand the 3 Stage approach to validation and its applicability internationally.
- Apply tools and techniques to help clarify validation deliverables.
- Appreciate the importance of science and risk-based approaches to validation and alignment to ICH Q8, Q9 and Q10
