Regulations & quality and bioproduction

New

Level 1 -

Fundamentals of Quality by Design to Strengthen Your Company’s R&D

Presentation

Why participate?

Optimize development costs and timelines while enhancing innovation and flexibility. Integrate QbD into professional practices to improve product quality

Training Context:

Quality by Design is an innovative methodological approach increasingly applied in pharmaceutical companies and supported by regulatory agencies. QbD builds quality into the product from the design stage by identifying and controlling sources of variability to ensure consistent outcomes. This method reduces costs and timelines by minimizing rework and improves regulatory compliance by facilitating approvals. By using advanced analytical tools, QbD promotes innovation and flexibility in development processes.

Learning objectives

  • Understand the QbD approach in relation to cGMP
  • Know the fundamentals of the QbD methodology
  • Learn the main QbD tools: QTPP, risk analysis, DoE, and design space
  • Understand the links between product CQAs and process CPPs
  • Recognize the need for a multidisciplinary QbD approach: process development, analytical development (PAT and in-line measurement), quality assurance, and regulatory affairs

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

Analytical R&D and QC, QA team leaders, CMC regulatory affairs writers, project managers, researchers, process development engineers and technicians

Prerequisites

Good knowledge of QbD or having completed the training "Fundamentals of Quality by Design to Strengthen Your Company’s R&D"

Duration

1 day, 7 hours

Price

750 € HT (Public)
600 € HT (Membre)
300 € HT (Académique)

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

Trainers

Catalogue de formations-MabDesign-2023.pdf (7)

Christian

VALENTIN

Expert Consultant indépendant

Rating

Participant satisfaction rate :

4.5/5
(average over 14 people).

Return rate of satisfaction questionnaires :

100%

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