ICH Q8 / ICH Q11 Training Course - From QbD to Process Validation
Im Auftrag der European Compliance Academy

ICH Q8 / ICH Q11 Training Course - From QbD to Process Validation Im Auftrag der European Compliance Academy

Copenhagen, Denmark

Seminar Nr. 15664


Die Veranstaltung hat bereits stattgefunden

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


Dr Hiltrud Horn, Horn Pharmaceutical Consulting

Dr Jochen Felix Kepert, Roche Diagnostics

Dr Rainer Lang, Roche Diagnostics

Dr Line Lundsberg-Nielsen, NNE Pharmaplan


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.

In workshops, you will discuss elements and methodologies associated with ICH Q8 and ICH Q11. 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 coming Q12 will open the door to a powerful era of refined, modern and efficient pharmaceutical development and optimisation for those companies who are ready to invest in this new paradigm.


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


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
Key Concepts of QbD and how they all link together
  • Quality Target Profile (QTPP)
  • Critical Quality Attributes (CQAs) and Critical Process parameters (CPPs)
  • The role of Material Attributes
  • Design Space
  • Control Strategy
  • Continuous Improvement
Interactive Sessions: QbD for Drug Products
  • QTPP – CQA – CPP (for different kinds of formulations, e.g. Oral formulations
  • (Tablets, vs. Biotech vs. Vaccines)
  • Typical points of discussions within teams
Workshop Sessions:
  • Establishing a design space (Design of Experiments, DoE)
  • Control Strategy
Development of the Drug Substance /Drug Product
  • Strategies to consider for Development
  • Key Points and potential pitfalls
  • Ways to success for the submission of the Dossier
  • Typical questions from Regulators
How the enhanced Control Strategy links back to the QTPP and leads to effective controls of CPPs and ensures the CQAs meet their Specifications (small molecules).
  • Traditional versus enhanced Control Strategy
  • The link between QTPP, CQAs, CPPs, Design Space and Enhanced Control Strategy
  • Implementation of the Control Strategy into Manufacturing
  • Link between Control Strategy and Batch Release Strategy
  • Post-approval lifecycle management
Identification of CQAs for a Biotech Product & Establishment of an Enhanced Control
  • Strategy that ensures the CQAs meet their Specifications
  • The link between QTPP, CQAs, CPPs, Design Space and Enhanced Control Strategy
How to apply PAT during Pharmaceutical Development
  • What is PAT and how is PAT related to QbD
  • Introduction to PAT tools: Process Analysers, Design of Experiments, Multivariate Data Analysis, Process Control, Knowledge Management and Continual Improvement
  • Examples of PAT applications during development
QbD and the link to Process Validation and Continued/Ongoing Process Verification
(Examples from both small molecules and biotech)


GMP Seminare nach Thema

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