Half-day training and discussion
During this training, you will acquire a basic knowledge of the following:
- The framework in which QbD is set
- Why Quality by design is the future.
- How one can start applying the Quality by Design framework
Why this topic?
Within the (bio-)pharmaceutical industry, the quality of the products being manufactured must be guaranteed at all times. In the previous era, the agencies were focused on end quality product testing. The view of quality gurus in the 20th century: “Quality cannot be tested into a product, it must be there in the first place” is how quality is currently being treated by the agencies.
Specific knowledge is required to introduce the concept to management and the project engineers that perform this new quality approach.
What can you expect during the training?
- You will acquire basic knowledge of QbD and a basis to start applying it to your projects.
- You will acquire a basic overview of the current Pharmaceutical challenges and of Quality Gurus that reshaped other industries
- The content of the ICH GMP guidelines will be explained during this session.
What is the result in your daily work?
The opportunity to work in a QbD fashion and apply the risk assessment approach in your daily work. A QbD framework to hold your current validation approach against and the ability to link any operation with this framework
- Participants have a good insight into the ICH guidelines
- Participants will be able to grasp the concept of QbD
- Participants will understand the PRO & CONs of the framework
This workshop is intended for anyone who has struggled with the guidelines and wants to understand how it can be applied. No prior knowledge is required, but an understanding of a product lifecycle is a plus (tech transfer → commercial manufacturing → termination).
All participants who attend the complete workshop receive a certificate.
- Overview of the background in which QbD is set
- Introduction to broader quality concepts
- Why QbD
- ICH 8, 9 & 10 (Pharmaceutical Development, Quality Risk Management & Pharmaceutical Quality System)
- Design space
- Control strategy
- Risk assessment drill down (methods on how to turn QbD into practice)
- FDA process validation guidance 2011
- Revisit the guidance with QbD in mind