Dr Christian Palmes
Bayer
Referent:innen
Dr Steffen Groß
Paul-Ehrlich-Institut (PEI)
Dr Line Lundsberg-Nielsen
NNE
Dr Martin Maus
Boehringer Ingelheim
Dr Andrea Staab
Boehringer Ingelheim
Note: All times mentioned are CEST.
Zielsetzung
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.
During this Live Online Training elements and methodologies associated with ICH Q8 will be discussed. All this will be illustrated with examples and case studies.
During this Live Online Training elements and methodologies associated with ICH Q8 will be discussed. All this will be illustrated with examples and case studies.
Hintergrund
The impact of ICH Q8, Q9, Q10, and Q11 is changing both the regulatory expectations and the strategies of Pharmaceutical Development. This impact will continue to grow, especially in view of the 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 patients’ 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 are 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 ICH 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.
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 patients’ 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 are 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 ICH 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.
Zielgruppe
This Live Online Training addresses 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 Elements.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Programme Day 1
Introduction to QbD – Setting the Scene
- Drug product development at a glance – from first in man to marketing authorization
- Pharmaceutical QbD: Quo vadis?
- Application of QbD principles to drug product development
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
Quality Risk Management and Control Strategy
- Objectives of Quality Risk Assessment (QRA) as part of development
- Overview on risk assessment tools
- Introduction to Process Risk Map
- Introduction of risk-based control strategy development
Q&A Session 1
Case Study DoE
- Why we use DoE in the pharmaceutical development
- Example: DoE for formulation selection / optimization
- Example: DoE for manufacturing process optimization
- DoE vs “traditional” approach – when to use which
QbD Toolbox: DoE, PAT, Basic Statistics
- Value-added use of QbD tools – generic approaches and tailored Solutions
- Examples for different unit operations and variable problems
Q&A Session 2
Programme Day 2
Reports and Documentation
- Development Reports
- Transfer protocols and reports
- Control Strategy and link to the submission dossier
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)
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
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
Q&A Session 3
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Pharmaceutical Development Manager"
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E-Mail: info@concept-heidelberg.de
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