New Approach of Process Validation

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