Regulations & quality and bioproduction

New

Level 1 -

Quality by Design Applied to Analytical Methods (AQbD): Toward a Scientific and Effective Approach to Analytical Processes

Presentation

Why participate?
Acquire sufficient knowledge to implement the AQbD approach in your company

Training Context
The Quality by Design (QbD) approach has become standard practice for developing, describing, and implementing drug manufacturing processes. It has significantly improved the understanding of pharmaceutical manufacturing and provided greater flexibility. This methodology can also be applied to analytical methods (AQbD) and is described in the new regulatory guidelines ICH Q14 and ICH Q2(R2).

Learning objectives

  • Understand the AQbD (Analytical Quality by Design) approach
  • Learn the fundamentals of AQbD
  • S’approprier les principaux outils de l’AQbD : ATP, analyse de risques et analyses statistiques
  • Monitor the analytical method

Teaching methods

The training uses interactive methods to encourage experience sharing among participants and reflective thinking on their practices: slide presentations, case studies, questionnaires, and peer discussions.
Participants will receive training materials, including the full slide deck presented during the course and additional documents to address specific questions.
Knowledge acquisition will be assessed through a questionnaire. A group correction will be conducted with all participants. A certificate of completion will be issued to each participant.

Audience

People working in analytical development, quality control, quality assurance, and regulatory affairs

Prerequisites

Basic knowledge of analytical development and method validation required

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

Vincent Bertholet.pdf

Vincent

BERTHOLET

Principle Statistician
Quality Assistance
Catalogue de formations-MabDesign-2023.pdf (19)

Damien

MOUVET

Sr Scientific Manager
Quality Assistance

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