New
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).
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.
People working in analytical development, quality control, quality assurance, and regulatory affairs
Basic knowledge of analytical development and method validation required
Prices: Excluding tax, as the training is not subject to VAT.
In-house training rate: Please contact us.
Registering online or by e-mail is a pre-registration. We will process your request within one week:
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