Regulations & quality and bioproduction

Level 2 -

Design of Experiments for QbD

Presentation

Why participate?

Optimize biopharmaceutical development and manufacturing by identifying critical parameters, improving efficiency and quality, enhancing regulatory compliance, and fostering innovation.

Training Context:

Quality by Design (QbD) is a systematic approach to ensuring pharmaceutical product quality from the earliest design stages, integrating both regulatory requirements and patient needs.
Design of Experiments (DoE) is a key tool in this approach, allowing identification and control of critical variables that impact product quality.
This training introduces these concepts through a geometrical approach and emphasizes practical application and result interpretation. Participants will work with real datasets using chemometric software such as Design Expert® and MODDE®, gaining essential skills to optimize development processes and increase result reliability.

Learning objectives

  • Discover the fundamentals of Design of Experiments (DoE) to implement a Quality by Design (QbD) approach
  • Improve the planning of experiments (minimizing both number and cost)
  • Optimize product and process quality
  • Independently use software tools for Design of Experiments

Teaching methods

Teaching methods include interactive learning, experience sharing, reflective practice, presentations, case studies, questionnaires, and peer discussions.
Includes:
Q&A sessions for clarification
Knowledge assessment
Participant satisfaction survey

Audience

Researchers, scientists, and engineers

Prerequisites

Good knowledge of QbD or prior completion of the “Fundamentals of Quality by Design to Strengthen Your Company’s R&D” training

Duration

2 days, 14 hours

Price

1,500 € HT (Public)
1,200 € HT (Membre)
600 € HT (Académique)

Prices: Excluding tax, as the training is not subject to VAT.
In-house training rate: Please contact us.

The benefits of our courses

  • Personalized support
  • Skills assessment
  • Certificate of completion
  • Training quality evaluation
  • Accessible to people with disabilities (please contact us)

How to access and deadlines

Registering online or by e-mail is a pre-registration. We will process your request within one week:

  • Contact by e-mail or telephone
  • Sending of administrative and educational documents: training agreement, training programme and positioning questionnaire.

Signing the training agreement commits the company or individual to the training course. Cancellation conditions are specified in the training agreement.

When no session date is specified, pre-registration allows us to note your interest in a programme, and we will keep you informed as soon as a new session is organised.

For more information, contact Daphné Brisard: 02 47 36 63 18 or formation@mabdesign.fr