8 - 10 April 2024
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 capture the scientific knowledge built during analytical method development and better share this knowledge internally or with the regulatory bodies. This will facilitate efficient and risk-based approval of analytical methods and create flexibility for post-approval changes and for 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. Analytical results provide data, translated into information, to make decisions on the safety, efficacy, and quality of medicines. This decision-making process should be science-centred to acknowledge the uncertainty of a measurement and to reduce the 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 that fulfil the anticipated requirements.
The process starts with predefined objectives and a handshake between project and the analytical department. It 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, thus reducing 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 2024 brochure.
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.
- Theory on Analytical Quality by Design
- Detailed training on the AQbD flow and the specific modules:
- Analytical Request and Analytical Target Profile
- Technologies selection
- Critical Method Parameters
- Method Development, including Design of Experiments
- Method Implementation
- Method Verification
- Procedure life cycle management
- How to implement AQbD within your organization
- Exercises 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
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 training will be provided by Cari Sänger - van de Griend (Kantisto) and Ewoud van Tricht (Sanofi). 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 products, 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 development costs and time.
The next course is planned for 8 - 10 April 2024 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 February 2024 will result in a full refund minus a 20 % processing fee. Cancellation made after 1 February 2024 will not be refunded, but registration can be transferred to another person. Deadline for registration: 1 March 2024, after this date, only upon availability.
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!