ICH Q8 / ICH Q11 Training Course - From QbD to Process Validation - Live Online
23/24 November 2021
Course No. 18568
Speakers
Dr Line Lundsberg-Nielsen
NNE
Note: All times mentioned are CET.
Objectives
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.
Background
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 Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html 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.
Development of the Drug Substance/Drug Product (incl. Biotech)
Strategies to consider for development
Key points and potential pitfalls
Ways to success for the submission of the dossier
Typical questions from regulators
16.30 - 17.00 h
Q&A Session 2
Programme Day 2
09.00 - 10.00 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
10.00 - 11.00 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)
11.00 - 11.15 h Break
11.15 - 12.15 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
12.15 - 13.00 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 - 13.30 h
Q&A Session 3
This course is part of the GMP Certification Programme "ECA Certified Pharmaceutical Development Manager" Learn more
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Seminar Programme as PDF