Regulations & quality and bioproduction

Level 2 -

Continuous process improvement: the contribution of PAT to the quality by design approach

Presentation

Why participate?

Master the tools that allow for real-time monitoring and control of manufacturing processes, thereby improving product quality, optimizing production, and ensuring regulatory compliance.

Training Context:

Participating in a training session on Process Analytical Technology (PAT) equips professionals with the knowledge and techniques to monitor and control manufacturing processes in real time. Integrating PAT into operations helps companies reduce non-compliance costs, accelerate product development, and meet regulatory requirements.
PAT strengthens the Quality by Design approach by ensuring rigorous control of quality parameters and supporting continuous process improvement.

Learning objectives

  • Understand the principles of PAT: Learn about the technologies and techniques used to monitor manufacturing processes in real time
  • Optimize production: Use PAT to improve quality, increase process efficiency, and reduce costs
  • Integrate PAT into Quality by Design (QbD): Enhance QbD with PAT to enable continuous control of critical parameters
  • Ensure regulatory compliance: Apply PAT to meet regulatory expectations and accelerate the development of new products

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

Bioprocess R&D, Analytical Support and Quality Control, Quality Assurance coordinators, CMC Regulatory Affairs writers, Project Managers, Researchers, Process Development Engineers and Technicians

Prerequisites

A solid understanding of biopharmaceutical development and QbD, or prior completion of the “Fundamentals of Quality by Design to strengthen your company’s R&D” training.

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

Independent Expert Consultant

Rating

There is no rating available because this training session was never carried out.

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

Jean-Roch Fabreguettes

MEARY

Directeur Médical et Personne Responsable du Centre MEARY de thérapie cellulaire et génique au sein de l’hôpital Saint-Louis à Paris

Jean-Roch Fabreguettes est un spécialiste de la recherche translationnelle et des phases précoces de développement clinique des médicaments de thérapie innovantes (MTI). Pharmacien, titulaire d’un doctorat de l’Université de Montpellier 1, il a travaillé plus de 25 ans dans le domaine et a contribué, pour des équipes académiques comme pour des start-ups, à la réalisation de plus de 30 programmes de recherche sur différents types de MTI : thérapie génique in vivo ou ex vivo, thérapie cellulaire, ingénierie tissulaire… Il est actuellement Directeur Médical et Personne Responsable du Centre MEARY de thérapie cellulaire et génique au sein de l’hôpital Saint-Louis à Paris. Le centre MEARY est une plateforme de l’Assistance Publique – Hôpitaux de Paris (AP-HP), dédiée à la fabrication de médicament de thérapie innovante expérimentaux. Laboratoire membre de l’ISCT, il est autorisé par l’ANSM et dispose d’un certificat GMP. A ce titre Jean-Roch Fabreguettes est impliqué dans le développement clinique et la fabrication de nombreux MTI : CAR-T cells, lymphocytes T régulateurs, cellules stromales mésenchymateuses…

Précédemment, Jean-Roch Fabreguettes a été expert Qualité (CMC) auprès de l’ANSM durant 9 ans et a conseillé différentes sociétés de biotechnologies. Il est un intervenant régulier pour l’Université Paris Cité et un membre actif de l’ISCT et de réseaux nationaux et internationaux sur les MTI (UNI-TC, Join4ATMP).