Live Online Training: ICH Q8 / ICH Q11 Training Course

Live Online Training: ICH Q8 / ICH Q11 Training Course

Course No 18392

Note: All times mentioned are CEST.


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Dr Carmen Boix Bernardini, Almirall
Dr Steffen Groß, PEI
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Dr Line Lundsberg-Nielsen, Lundsberg Consulting


You will be updated on the latest regulatory developments and learn how to apply the respective paradigms in Pharmaceutical Development to be better able to design strategies for the implementation of Quality by Design (QbD)  according to ICH Q8 and ICH Q11.

During this live online training elements and methodologies associated with ICH Q8 and ICH Q11 will be discussed. All this will be illustrated with examples and case studies.


The impact of ICH Q8, Q9, Q10, and Q11 is changing both the regulatory expectations and the strategies of Pharmaceutical Development, and this impact will continue to grow, especially in view of the emerging ICH Q12 Guideline.

The QbD concept described in ICH Q8 and ICH Q11 have to be seen as an overarching paradigm and an interdisciplinary approach across the product lifecycle. It also systematically emphasises enhanced product and process understanding throughout the product lifecycle.

Ideally, application of ICH Q8 and ICH Q11 elements already starts in the early design phase of a drug product where both patient needs and process design are considered. The QbD concept requires a comprehensive understanding of the chemical and physical nature of the individual active substance(s) and excipients, and of the way their attributes interact in the formulation and how they bare impacted by the manufacturing process. During the design phase, it is important to establish the Quality Target Product Profile (QTPP), determine the Critical Quality Attributes (CQAs), identify Critical Process Parameters (CPPs) and Material Attributes (material CQAs) and to understand how the process parameters and material attributes affect the CQAs. The relationship between process inputs (material attributes and process parameters) and the CQAs is described in the Design Space and ensured during manufacturing with an enhanced control strategy, leading to improved process understanding, greater operational flexibility and opportunities for more efficient life cycle management activities.  

ICH Q8 combined with the new Q12 will open the door to a powerful era of refined, modern and efficient pharmaceutical development and optimization for those companies who are ready to invest in this new paradigm.

Target Group

This live online training is designed for all scientists, engineers, managers and executives from Pharmaceutical and Biotech Development units and support functions to Manufacturing, including Quality Assurance and Technical/CMC Regulatory Affairs, who are involved in the implementation of ICH Q8/Q11 elements.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Programme Day 1
09.00 - 09.15 h Welcome and Introduction
09.15 - 10.15 h
QbD for Drug Products: Background and Practical Aspects
  • Essentials to know about QbD
  • Steps for defining QTPP/CQA/CPP
  • Benefits of the QbD Approach
  • Practical Examples
10.15 - 10.30 h Coffee Break
10.30 - 11.45 h
QbD - Regulatory Perspective
  • Current state of PAT & QbD implementation and regulatory challenges
  • Quality by on-line (PAT) measurements
  • Real time release testing: general considerations
  • Going forward: ICH Q12 / Q13 / Q14
11.45 - 12.15 h
Q&A Session 1
12.15 - 13.15 h Lunch
13.15 - 14.00 h
QBD for Drug Products
  • QTPP – CQA – CPP for different kinds of formulations, e.g. Oral formulations (Tablets, vs. Biotech vs. Vaccines)
14.00 - 15.00 h
Development of the Drug Substance (Focus on Biotech)
  • Strategies to consider for development
  • Key points and potential pitfalls
  • Ways to success for the submission of the dossier
  • Typical questions from regulators
15.00 - 15.15 h Coffee Break
15.15 - 16.45 h Coffee Break
DoE examples for API development
  • DoE theory:
    • Resolution and confounding
    • Overview of available DoE designs
    • Basic statistics – understanding my software analysis
    • Intuitive interpretation of the design: mapping
  • Practical approach to DoE aimed to reduce the number of experiments:
    • Risk assessment: Fishbone (Ishikawa) diagram; FMEA (failure Mode Effect Analysis) and RPN analysis (Risk Priority Number)
    • Choosing the design
    • Practical tips for execution
16.45 - 17.15 h
Q&A Session 2
Programme Day 2
08.30 - 09.30 h
QbD for Drug Products: Typical Points of Discussions within Teams
  • Keypoints and potential pitfalls
  • Ways to success for the submission of the dossier
  • Typical questions from Regulators
09.30 - 10.30 h
How the QbD derived Control Strategy defines Process Validation
  • QbD and PAT as an enabler for gaining Process Understanding and designing the process and the control strategy, PV stage 1 (establishing the control strategy)
  • Different approaches to PV/PPQ depending on the type of control strategy, PV stage 2 (traditional, continuous process verification or hybrid approach used to verify the control strategy)
  • Ongoing/Continued Process verification, PV stage 3 (verifying the validity and robustness of the control strategy)
10.30 - 10.45 h Coffee Break
10.45 - 11.45 h
Process Validation – case study (small molecule drug product
Case study related to the previous presentation (PV stage 1 and 2)
  • Case example of a solid dosage form process enabled by a QbD approach
  • Establishing the control strategy: Examples of the application of PAT/RTRT
  • Validation of the process – verification of the control strategy
11.45 - 12.30 h
Ongoing Process Verification and lifecycle approach of a process established from QbD principles
  • Continuous process verification versus continued/ongoing process verification (PV stage 3)
  • Case study – the continuation of the example from above (PV stage 3)
  • ICH Q12, performance-based control and the link to PAT
  • Life cycle management of the product, process and control strategy opportunities for a product developed using of a QbD principles
12.30 - 13.00 h
Q&A Session 3

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