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.



PROGRAM BEING FINALIZED


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
form pictogram
EXHIBITION 
stand pictogram

  

     


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
Tuesday January 30
09: 15 - 18: 00
 

Introduction of the congress
ELI LILLY - Alain NONN

Application of the principles of QbD to characterize and validate a biotech process in a "lifecycle" approach
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

Feedback from the technology transfer of a biological product enre 2 commercial sites
ELI LILLY - Valérie TISSIER

Poliovirus bulk production - Changeover Validation approach
GSK VACCINES - François VANHERSECKE

   
           
      18: 00 - COCKTAIL & DINNER    
           
     

 

Wednesday January 31 2018

   
     

 

08: 30 - Welcoming participants

   
           
  CONFERENCES
Wednesday, January 31
09: 00 - 12: 00
 

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

Maintains validated status
ASPEN - Sabrina GALLAY & Romane VEGAS

From development to industrialization: feedback on a practical case 
OCTAPHARMA - Virginie FRANÇOISE & Eric PENN

Statistics and product life
ELI LILLY - Emeric GIRAUD

   
           
      Conclusion and perspectives of A3P mastery days    
         
      Overview of GSK and EFS site visits    
           
      12: 45 - BREAKFAST BREAK    
           
   

Site visits - Wednesday 31 January

Departure from Lille Grand Palais: 14h00
Back to Lille Grand Palais: 17h30 at the latest
   
   


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

 

   

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