7 - 9 October 2024

Enhancing Analytical Method Development and Knowledge Sharing

Do you want to break down the guidelines (ICHQ14, ICHQ2(R2), and USP <1220>) into a practical AQbD workflow with tools? Do you want to take the opportunity to capture the scientific knowledge built during analytical method development and better share this knowledge internally or with the regulatory bodies? The AQbD tools will facilitate efficient and risk-based development and validation of analytical methods and for keeping product and process control strategies scientifically sound and fit-for-purpose. This course demystifies and presents AQbD in a digestible way.

The AQbD process starts with defining objectives and a handshake between project and analytical development. It includes identifying critical method parameters, risk-based decision making, and continuously following and improving the 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.

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

• Background of 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
• Sharing examples and experiences from industry
• Templates 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 (further) implement 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) and Ewoud van Tricht (Sanofi). We share years of experience applying and implementing the principles of AQbD within (bio)pharmaceutical companies. By doing so, we improved the coherence between analytical methods and the process and quality profile of the 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 development costs and time.

Registration

The next course is planned for 7 - 9 October 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! Early-bird registration fee when registering before 1 July 2024. Refund policy: written cancellation before 1 August 2024 will result in a full refund minus a 20 % processing fee. Cancellation made after 1 August 2024 will not be refunded, but registration can be transferred to another person. Deadline for registration: 1 September 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

• AQbD demystified and presented in a digestible way!
• This course is an excellent way to learn the AQbD concepts.
• 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.
• The rhythm of the training was perfect! Well fragmented, good timings, exercises at the right time.
• The exercises in this course took me over the fear of starting to use AQbD myself.
• Many practical examples that give grip on the topic. The exercises clearly demonstrated and underlined the need for an AQbD mind set.
• I liked the exercises and the playfulness of them and the teachers.
• The teachers had a good balance, they have lots of experience and complement each other.
• It is very inspiring to see the course leaders talk so enthusiastically about their field.
• 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!
• I’m so exited to go back to the lab to develop a new method with all I learned!

Feedback from other courses.