Bioprocess Characterisation, Qualification and Validation - Day 2Friday, 14 November 2025

Introduction to regulatory guidance

• Assessing and understanding the relevant ICH guidance: Q8, Q9, Q10, Q11, Q12, EMA and FDA process validation related guidance
• Gain an understanding of the rationale behind the requirements
• Overview of other relevant guidance

Traditional and enhanced pharmaceutical development

• Comparison of traditional and enhanced development
• Generation of process knowledge
• Learn how to link product and process characterisation together
• Overview of development throughout the lifecycle

Quality by Design (QbD) Concept and Approaches & Exercises on TPP, QTPP, CQAs, CPPs

• Gain a practical guidance to QbD
• Examine the various hybrid approaches
• How to apply QbD
• Evaluate the strengths and weaknesses QbD
• Practical considerations of applying a QbD approach

Risk assessment methodologies & practical considerations & Exercises

• Fields of application
• Different risk management methods and tools
• Learn how to assess and manage risks
• Examples for Failure Mode, Effect and Criticality Analyses (FMECA)

Stages in Development 1, 2 and 3

• Examining design, qualification and validation
• Discover what to do and when
• Defining the process and ranges

Process characterisation small-scale process model utilisation exercises

• Learn how to use small process models
• Assessing the strengths and weaknesses of using a small process model
• Understand the need for qualifying to a large-scale process
• Ensuring your small-scale data is reflecting large scale production
• Proven Acceptable Range studies and Multivariate Analyses

Control strategy development and implementation & Exercises

• Overview and examples of process controls (USP & DSP)
• Importance of analytical method
• Developing a process control strategy including ranges
• Process control loops & hierarchy
• Control charts data analyses
• Defining process & product and ranges and limits
• Examining the process and identifying critical process parameters
• Process parameter categorization & how to validate

Process Performance Qualification

• Prerequisites
• How to perform a process performance validation
• Studies to be included
• Sampling plan
• Protocol & report requirements

Continue process verification and validation

• Monitoring performance once approval has been granted - a batch to batch approach
• Annual product reviews
• Continuous process improvement

Regulatory considerations

• Capturing information for the regulatory dossier
• Practical advice and guidance

Conclusions and Feedback