26 - 28 June 2023
Analytical procedures fit for decision making
Are you ready for the new and upcoming ICH Q14 and USP <1220> guidelines and the complementary revision (R2) of ICH Q2? These forthcoming guidelines are designed to fill a void in the toolbox of analytical method development. They provide the opportunity to present the scientific framework build during development in the validation reporting of the analytical methods. By following and implementing these guidelines and appropriate tools, authorities will facilitate efficient and risk-based approval of analytical methods with flexibility for post-approval changes and keeping product and process control strategies scientifically sound and fit-for-purpose. The guidelines are almost ready, and this promising and desired tool? Analytical Quality by Design.
Analytical methods are employed throughout pharmaceutical development and manufacturing. They provide data, translated into information, to make decisions. This decision-making process should be science-centered to acknowledge the uncertainty of a measurement and risk of making the wrong decision. Analytical Quality by Design (AQbD) is a structured risk-based approach that supports the process of effectively designing analytical procedures that focus on the intended purpose and fulfil the anticipated requirements. This approach extends beyond the application of design of experiments, or even the method on its own.
The process starts with predefined objectives and a handshake between project and the analytical department, includes identifying critical method parameters, risk-based decision making and continuously following and improving your procedure. The resulting method is better understood, more robust and in control. This reduces the need for troubleshooting and costly reanalysis. The knowledge and decisions made during development are captured, shareable and reusable throughout the whole pharmaceutical life cycle.
See here for the 2022 brochure.
For whom
This course aims at managers and scientists who want to apply a scientific AQbD approach in their daily work or gain knowledge on how to start implementing AQbD within their organization.
Course content
- Theory on Analytical Quality by Design
- Detailed training on the AQbD flow and the specific modules:
- Analytical Target Profile
- Technologies selection
- Critical Method Parameter
- Method Development
- Implementation
- Method Verification
- Procedure life cycle management
- How to implement AQbD within your organization
- Hands-on practice for each module
- Rapid learning cycles by combining theory and exercises
- Discussions in an open and positive environment
- Real examples and experiences from industry
- Template you can adapt for your own organization
Learning outcome
This 3-day course will provide time to network and discuss with fellow scientists. After this course you have learned how to apply AQbD in your daily work and are motivated to start implementing this approach within your organization. A training certificate, practical templates and hand-outs will be provided.
The trainers
The training will be provided by Cari Sänger - van de Griend (Kantisto), Ewoud van Tricht (Janssen), Lars Geurink (Janssen), and Eline van den Berg (Byondis). We share years of experience applying and implementing the principles of AQbD within our companies. By incorporating AQbD in our method development process, we improved the interconnection between analytical methods and the process and quality profile of our product, strengthening the concept of “right analytics at the right time”. AQbD increased our level of control and understanding of the analytics as well as reduced our developmental costs and time.
Registration
The next course is planned for 26 - 28 June 2023 in Naarden-Bussum (25 km from Amsterdam). For more information and registration, contact Kantisto. There is a maximum of 20 attendees, make sure you register in time! Refund policy: written cancellation before 1 April 2023 will result in a full refund minus a 20 % processing fee. Cancellation made after 1 April 2023 will not be refunded, but registration can be transferred to another person.
Kantisto also offers on-site consultancy, implementation support, and courses with content tailored to your needs.
Please send an e-mail or use Kantisto's contact form.
Feedback from previous courses
- Everyone in our organization should do this course. Many applicable solutions were discussed in a comprehensible way that we can apply immediately.
- The course covers the fundamentals of the AQbD and it gives the courage to try it for yourself.
- My basic knowledge about AQbD was mostly on DoE robustness. I now feel secure that the course helps me to support my group in every AQbD subject.
- The course made me better understand the whole workflow and the relationship between all different steps.
- Many practical examples that give grip on the topic. The exercises clearly demonstrated and underlined the need for an AQbD mind set.
- The teachers had a good balance, they have lots of experience and complement each other.
- There was plenty of opportunity to ask questions and the speed of the training was flexible and adapted to our uptake.
- I have really enjoyed this course and look forward to use all that I’ve learned to my method development at work. Thank you very much!