About

Quality by Design (QbD) is a methodology used in product development or optimization projects.
The goal of this development strategy is to obtain a holistic understanding of all potential variables which might affect the quality, efficacy, and safety of the drug product.

The biggest benefit is that quality could be designed into the product instead of purely relying on end-product testing (Quality by Testing approach).
Using such an approach requires the input and experience of a multidisciplinary team that determines the potential risk of material and process variables on product quality.

Based on this initial risk assessment, additional experimental designs could be designed and executed to further characterize the product and manufacturing process.
All the generated product and process understanding will be used to define a design space and suitable process control strategy resulting in a consistent product quality.

During this course, the QbD principle and the different steps needed for this approach will be presented in combination with examples from the field to apply and discuss from a practical point of view.

The following blocks will be addressed:

  • General principles and importance of the QbD approach
  • Role of Process Analytical Technology (PAT) in QbD and potential of PAT-based Continuous Manufacturing (CM)
  • Importance of Design of Experiment (DoE) methodology supporting product and process characterization studies
  • Practical examples to contextualize and apply theoretical knowledge in case studies drawn from pharmaceutical manufacturing.

People involved in drug product and manufacturing process development projects. A multi-disciplinary approach is needed during the risk assessment of potential material and process variables. Therefore, people from different departments (R&D, quality, regulatory, manufacturing, etc…) could benefit from using the QbD methodology for their development or optimization projects.

The online workshop will be a mixture of theoretic presentations, case studies and practical examples.

Lecturers
Maxim van den Steen
Info

Maxim van den Steen

Managing Partner of Qualicon Development – Pharmaceutical Consultant for QbD

Maxim Van den Steen is an Industrial Pharmacist who investigated the mixing mechanics of continuous melt granulation processes during his master thesis at Ghent University. As a member of the R&D department, he was involved in multiple drug discovery and development, new product introduction and technology transfer projects (J&J, Ardena, Antwerp Drug Discovery Netwerk, Qualiphar). In July 2023, he founded a start-up company specializing in the development of sustainable products manufactured via CM technologies where quality is designed into the product and assured via PAT-based CM technologies.


Online Training – 1 module

16 September 2024 from 09:00 am to 01:00 pm CEST

Few days before the online training you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 480,00* (until 26 August 2024)

Ordinary: € 610,00*

Freelance – Individual – Academy – Public Administration**: € 410,00*

for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Mara Claudia Algarotti
Mara Claudia Algarotti
Training Manager & MW Operations
Printable Version
At the end of the training, you will be able to
Risultato atteso
Compose a multi-disciplinary team within the company that provides the needed input/experience to set up a clear quality target product profile (QTPP) and identify initial risk factors that could affect product quality, safety and efficacy
Risultato atteso
Define relevant product and process characterization studies to generate a proper level of product and process understanding
Risultato atteso
Use the outcome of additional studies as a basis for a residual risk assessment, the definition of a design space and a suitable control strategy. This product and process understanding&control are crucial requirements for future process validation resulting in a robust manufacturing process
Risultato atteso
Use the existing product and process understanding, gathered during the development phases, as a supportive tool for period quality reviews, root cause analysis and lifecycle management projects

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>