Mastering Quality By Design
A Comprehensive Webinar Series on QbD and DoE in Drug Development
Join us for a journey through the realm of Quality by Design (QbD) and Design of Experiments (DoE) with our dedicated webinar series, offering practical insights and real-world applications!
Delve into the intricacies of drug product development and statistical strategies alongside our interdisciplinary team of experts from Evotec's API, Drug Product Development, Quality Assurance and Pharmacometrics disciplines who are ready to share their wealth of knowledge and experience.
Explore the entire series below and sign up for the sessions that resonate with your interests!
Part 1 - Watch on Demand
Unlocking Quality by Design: A Comprehensive Introduction to QbD Principles in Drug Product Development
This first seminar aims to offer a comprehensive overview of the fundamental concepts and principles of Quality by Design (QbD), aligning with the guidelines outlined in ICHQ8, ICHQ9, and ICHQ10. Participants will gain insight into the key terminology associated with QbD. Our goal is to furnish attendees with a foundational understanding of how QbD principles are applied to Drug Product Development.
Throughout the session, attendees will be introduced to the various stages of the QbD product development cycle. They will learn how the establishment of a robust scientific understanding of product/process and the formulation of a control strategy are intricately linked to a risk-based development approach. This approach commences in the early phases of development and extends seamlessly through to the later stages of product life cycle management.
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Part 2 - Watch on Demand
QbD Success: Statistical Strategies and DoE Expertise
This webinar will focus on essential statistical services in Quality by Design applied to Drug Product development, with a particular emphasis on the expertise of our Biostatistics team in the field of Design of Experiment (DoE).
Attendees will learn how the application of advanced statistical methodologies can optimize process and product quality within the QbD framework.
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Part 3 - Watch on Demand
Application of Design of Experiments in API Chemical Development
This webinar will focus on the application of Design of Experiment (DoE) to chemical reactions. Despite a high resistance to use statistical tools in chemistry, the DoE can have many advantages when compared to the “one factor at time” strategy, reducing the quantity of reactions and identifying the interactions between factors with the definition of the optimal conditions.
Attendees will learn how the DoE can be applied to chemical reactions and how a DoE can be planned, identifying the factors that can affect the outputs. Additionally, case studies related to API development will be presented to show the real advantages of the DoE.
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Part 4 - Watch on Demand
Quality Risk Management
This webinar offers a high-level overview of fundamental concepts and the philosophy of Quality Risk Management (QRM) in accordance with ICHQ9 guidelines.
It is designed to equip participants with a foundational grasp of the key principles and tools of QRM specifically as they relate to drug product development. Through a real case study, attendees will gain an introductory insight into the steps of the QRM product development cycle.
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Part 5 - Watch on Demand
DoE Approach Applied to Twin Screw Wet Granulation Technology (TSWG) Platform: A Case Study
This webinar will show a case study where a 2-level fractional factorial DoE was applied during the development of a tablet formulation prepared by Twin Screw Wet Granulation (TSWG).
It aims to offer an insight to how Design of Experiment (DoE) is currently gaining increased importance as a statistical tool during the drug product development as it allows a more systematic understanding of the variables involved in formulation and manufacturing unit operations, in line with the QbD principles.
