Thursday 13th NovemberThursday, 13 November 2025

Introduction to regulatory guidance

· Assessing and understanding the relevant ICH guidance: Q8, Q9, Q10, Q11, Q12, Q13, Q14 EMA and FDA process validation related guidance

· Gain an understanding of the rationale behind the requirements

· Overview of other relevant guidance

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

· Gain a practical guidance to QbD

· How to apply QbD

· Practical considerations of applying a QbD approach

Risk assessment methodologies & practical considerations

· Fields of application

· Different risk management methods and tools - Examples for Failure Mode, Effect and Criticality Analyses (FMECA)

· Learn how to assess and manage risks

Stages in Development 1, 2 and 3

· Examining design, qualification and validation

· Discover what to do and when

· Defining the process and ranges

Control strategy development and implementation

· Overview and examples of process controls

· Importance of analytical method

· Developing a process control strategy including ranges

· Control charts data analyses

· 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

· Protocol & report requirements

· Continue process verification and validation

Conclusions and Feedback