Process Control

CPV / QbD / Statistics

Location
Hôtel Mercure Lyon Centre Château Perrache

Date

6 & 7 october 2021

Format

Conferences, Exhibition

Since 2019, three A3P Working Groups have been operating in parallel to finalise their work in 2021. These are the Working Groups :

  • Quality-by-Design ou QbD
  • Continued Process Verification ou CPV
  • Statistics

These three themes work in the same direction, i.e. process control. Indeed, QbD is a product and process design tool, based on science and risk analysis, which will enable the construction of a process control strategy, culminating in Process Validation.

Next, the CPV is a monitoring process that will confirm the validated state of the process over time. Statistical tools are used throughout the life cycle of the products, i.e. during these stages.

This coherence between these three themes led A3P to bring them together during the “Process Control 2021” days. Members of these three Working Groups will present lectures based on their work, i.e. product and process development, definition of control strategy, technology transfer, process validation, implementation of the CPV or integration of the CPV in the quality system.
The application of statistical tools, such as experimental designs, definition of sampling plans and validation criteria or control charts, will also be presented.
Speakers from outside the Working Group will share the implementation of these approaches.

To end these days, a round table will complete the exchanges between the congress participants and an exhibition of supplier companies will allow you to discover the market innovations available to industrialists.

Wednesday 6 october

Accueil des participants
13:30
Aspects règlementaires et maitrise des procédés par la mise en oeuvre du QbD, de la CPV et d'outils statistiques
Alain NONN - ALPHA PHARMA CONSULTING / Leader GIC CPV
14:00
Le QbD, la qualité à la source
Laure PLANCHE - FAB'ENTECH & Nathalie DALLY - ALLERGAN / GIC QbD
14:30
Pause café
15:00
Challenges opérationnels auxquels les industriels sont confrontés lors de l’établissement d’un design space par plan d’expérience
Aude COLIN - DEBIOPHARM & Benjamin VITRAT - FERRING / GIC QbD
16:00
DOE : Design of Experiments to enhance process understanding
Mourad MELLAL - CATALENT & Sebastien Le GUILLOU - SOLADIS / GIC STAT
16:30
Gain du QbD sur la partie industrielle
Cédric LE BARH - SANOFI & Sandrine DUCLOS - VIRBAC / GIC QbD
17:00
Fin de la journée
17:30

Thursday 7 october

Accueil des participants
08:15
Potentialiser l'approche QbD dans le cycle de vie du produit : Opportunités Règlementaires / ICH Q12
Romain LE DEUN - MERCK / GIC QbD & Johanne PIRIOU - AKTEHOM & Aurélie MIEZE-RICHARD - GUERBET / GIC ICHQ12
08:30
Méthodes statistiques pour les études de comparabilité : tour d’horizon et recommandations (GIC Stat)
Meriem ABDENNOUR - SANOFI PASTEUR / Catherine TUDAL - SOLADIS / Caroline LEVEDER - SANOFI / GIC Statistique
09:15
Pause café
10:00
Retour sur les travaux du GIC A3P Vérification continue des procédés
Estelle SCHUHLER - LFB BIOMEDICAMENTS / GIC CPV
11:00
Product and Process Trending along Continued Process Verification
Christophe AGUT - SANOFI
11:30
Déjeuner
12:00
Application du guide : Mise en œuvre de la validation en continu des procédés pour les nouveaux produits
Valérie HERON - SANOFI / GIC CPV
13:30
Application du guide : Mise en œuvre de la CPV dans le cadre du transfert de technologie d’un produit legacy dans une nouvelle unité de production
Murielle PERNEL - LILLY / GIC CPV
14:00
Retour d'expérience : implémentation et bénéfices du CPV
Cédric PAULOU - TAKEDA
14:30
Pause café
15:00
Table ronde avec nos experts / questions & situations associées aux thématiques QbD / Statistiques / CPV
Représentants des GIC QbD / Statistique / CPV
15:30
Fin de l'événement
16:30

Registration Form

Process Control

Price : 900 € + Membership A3P : 220 €

If you want to book a stand, please complete the form below.

Map of the exhibition

CompanyN° StandCompanyN° Stand
1CONFARMA5
ICARE26
37
4

Services included with the Table Top stand

  • A dedicated exhibition area (2m deep x 3m wide) on which you can install your products and communication tools: umbrella stand, roll-up, display, product, … A basic equipment including a 180 x 80 cm table, 2 chairs and 1 electrical connection (2kw) without circuit breaker, the loan of a Nespresso coffee maker with pods.
  • Breaks and meals indicated in the programme.
  • Unlimited Wifi.
  • A badge that allows you free access to the entire technical and scientific programme.
  • The list of participants in the event.
  • Possibility to register an additional person at the special “accompanying person” rate (500€ ).

Contact

Depending on your requirements and preferences, you can contact Ludivine BAYLE or Florian CANUTO :

Phone : +33 (0)4 37 28 30 46 ; +33 (0)4 37 28 30 51
Fax : +33 (0)4 37 28 30 60
E-mail : lbayle@a3pservices.com ; fcanuto@a3pservices.com
Adress : A3P, 30 rue Pré-Gaudry – Lyon 69007
On-site : Hôtel Mercure – Esplanade de la Gare, 12 Cr de Verdun Rambaud, 69002 Lyon

Accessibility