Prepare for ICH-Q14 and MLCM
When we learn how to develop an analytical method, we learn to pay attention to all the technical details. However, methods that are intended for extensive use need to meet more criteria than e.g. providing a good separation. What is phrased in the pharmaceutical industry and by regulatory bodies as “adequate for intended purpose” encompasses a lot of different requirements on top of the technical ones. In this course we learn that Analytical Quality by Design (AQbD) is a tool that supports the process to design and deliver a method that fulfils all the requirements. AQbD additionally helps to actively manage the method through its life cycle in the (bio)pharmaceutical industry.
See here for the 2020 brochure.
This course aims at scientists that want to develop and implement AQbD in their labs or that want to apply an AQbD approach in their daily work.
After this course, you will have a better understanding of the why and the how of analytical quality by design. You will be able to use this AQbD tool in your method development and focus on the purpose of the methods. You will get practical and pragmatic tips on how to implement AQbD in your organization.
- Analytical Quality by Design purpose and process
- Analytical Target Profile
- Technique choice
- Critical Method Parameters, Criticality and risk assessments
- Method development, optimisation and validation
- Multifactorial Design of Experiments
- Method application and life cycle management
- Examples from industry
The next course is planned for spring 2021. For more information and registration, contact Kantisto.
Kantisto also offers on-site consultancy and courses with content tailored to your needs.
Please send an e-mail or use Kantisto's contact form.