A3P

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maitriseprocedes 2018

A3P Process and product robustness days
30 and 31 January 2018 in Lille
  - Conferences
- Visit EFS or GSK website
- Exhibition

mastering 2018 processes

International health authorities require that drugs be produced according to validated processes with controlled inputs and controlled processes. This makes it possible to obtain a drug that conforms to the specifications in a systematic way and to avoid market failures. To achieve this, pharmaceutical companies rely on science-based development methods that lead to a control strategy for the manufacturing process. The transfer of technology makes it possible to set up a robust process whose control is demonstrated by process validation and adapted monitoring.

The days will cover the following areas:

  • Internship 1 - Development: application of the principles of Quality by Design
  • Internship 2 - Qualification and Validation: Technology Transfer and Process Validation
  • Internship 3 - Monitoring: assurance of the maintenance of the validated state.
Conferences will address these topics through presentations on feedback, the use of statistics and strategies implemented by laboratories producing in various fields. There will be rich exchanges, the concrete aspect of which will allow the replication of good practices.

Contact: Mylène RAT - Tel. 04 37 28 30 43
Mail. This e-mail address is protected against spambots. You need JavaScript enabled to view it.

 

ENTRIES
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EXHIBITION 
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PROGRAM - 30 and 31 January 2018
Lille Grand Palais - 1, boulevard des Cités-United, 59777 EURALILLE (FR)

 

 

 

           
     

Tuesday January 30 2018

   
 

 

08: 30 - Welcoming participants

   
  CONFERENCES
09: 15 - 18: 00
 

Introduction of the Days
LILLY - Alain NONN

Application of the principles of QbD to characterize and validate a biotech process in a "lifecycle" approach 
NOVARTIS - Stéphanie MONCHAUX & AKTEHOM - Johanne PIRIOU

Declination of Quality by Design: Feedback on vaccines applied to the methodology and implementation of the criticality analysis of existing processes 
SANOFI - Anne RIGOULOT

Sterile development and production: management and monitoring of a multi-site CDMO project
EUROFINS AMATSIGROUP - Stéphane FRANCES

Feedback from the technology transfer of a biological product between 2 commercial sites 
LILLY - Valérie TISSIER
 
Mastering aseptic processes in the preparation of cell therapy products and advanced therapy drugs used for therapeutic purposes: from regulation to practice
EFS- Anne FIALAIRE-LEGENDRE

Production of poliovirus - Changeover validation approach 
GSK VACCINES - Séverine VAN DYCK

Technology Transfer and change management - Case study 
LFB - Estelle DARNON

Feedback on the evolution of the manufacturing process by considering the life cycle of a product and the technico-regulatory expectations  
OCTAPHARMA - Virginie FRANÇOISE & Eric PENN

Product Lifecycle Management: a pragmatic & business oriented approach
GSK - Jean-Marie LAPORTE MORIN

   
     

 

18: 00 - Cocktail & Dinner

   
     

 

   
     

 Wednesday January 31 2018

   
     

08: 30 - Welcoming participants

   
  CONFERENCES
09: 00 - 12: 00
 

Statistics and product life
LILLY - Emeric GIRAUD

Maintaining the validated status 
ASPEN - Sabrina GALLAY & Romane VEGAS

Internship 1: Process understanding, define process control and sucess for continuous improvment
STERIS- Walid EL AZAB

   
      Conclusion and perspectives of A3P mastery days    
           
   

Site visits

   
     
Departure from Lille Grand Palais: 13h00
Back to Lille Grand Palais: 17h30 at the latest
   
   gsk logo  

GSK - Saint Amand Waters

Visit of the GSK Saint-Amand-les-Eaux site in the north of France near Lille. A unique site in Europe dedicated to the secondary production of vaccines. The site has state-of-the-art tools, implementing the best technologies to ensure the quality and safety of vaccines throughout the production process. The entire manufacturing process is carried out in insulators, from the formulation of vaccines to the filling of syringes and vials, to the loading of the freeze-dryers guaranteeing a perfect guarantee of sterility of the products.

   
     

EFS - Lille

EFS - Cell Therapy Unit at Hauts de France Normandie

Visit of the health center where samples are taken by therapeutic asheresis of the patients. Visit of the cell therapy unit: production area, quality control laboratory, cryopreservation area. The processis of manufacture is carried out under microbiological safety station in zone of controlled atmosphere. Cell therapy products are stored in nitrogen in dedicated and secure facilities. The quality control laboratory supports analyzes of cell therapy products: immuno-phenotyping, cell cultures, sterility tests and environmental controls.

   

Nearby Hotels

Novotel Lille Center Gares****
49 rue de Tournai - 59000 LILLE
Tel: + 33 (0) 3 28 38 67 00
Mail: H3165@accor.com
 
Ibis Styles Lille Center Gare Belfort***
172, rue de Paris - 59800 LILLE
Tel: + 33 (0) 3 20 30 00 54
Mail: H1384@accor.com
 

Ibis Center Grand Palais Hotel ***
1-3 Street Of The Mills Of Garance - 59000 LILLE
Tel: + 33 (0) 3 20 11 37 90
Mail:H9309@accor.com

 
Ibis Lille Gares Hotel ***
29, Av Charles St-Venant The Forum - 59000 LILLE
Tel: + 33 (0) 3 28 36 30 40
Mail:
H0901@accor.com 


TRANSPORTATION


Lille public transport: https: //transpole.fr/fr
Taxis Lille : 03 20 26 28 28 // 03 20 70 90 90