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a3p mastering processes

A3P Process and product robustness days
2 and 3 2016 February in Strasbourg
- Conferences
- Lilly site visits or Octapharma
- Exhibition

lilly logo 

logo octapharma

La mastering processes Manufacturing is an issue for all industries. Indeed, good control can limit production losses, obtaining good yields and good productivity, and provide the insurance market in particular.For good control, it is necessary to know the interactions between the product and the manufacturing process. This starts with the development and industrialization phases, continues with process validation, until monitoring routine batches.

Two days of conferences are offered under the aegis of the A3P to cover these topics. Different industry will present their approaches. This seminar will be held in Strasbourg 2 and 3 2016 February.

The themes are as follows :

New product developmentFor example: space design, risk analysis, design of experiments,
Transfer technologyIncluding staff training concepts and implementation for a production site,
Process Validation : Implementation according to the latest guidelines, continuous monitoring,
process monitoring : Statistical mastery of processes, process analytical technology, Defect Analysis and CAPA, process capability, retrospective evaluations (Annual Product Review ...).

Lilly site visits and Octapharma site will complete the program (Caution limited places).




      PROGRAM - Days A3P Process Control

     
CCI Strasbourg and Bas-Rhin, 234 BC. Colmar
BP 267 - 67021 STRASBOURG

→ www.pole-formation-cci.org
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Registration
PARTICIPANT

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     Tuesday February 02 2016

 

08h30

    Participants registration and coffee
 
  09h15 - Day Program Overview  
   
A3P Committee
 
09h30 - Innovative Drug Therapies: Industrial approach on a new
product family
   
Isabelle PAUTREL - CELLFORCURE LFB Group
 
  10h00 - A risk based approach to Primary Packaging control strategy
   
Henri HEBTING -LILLY
 
        Break and exhibition visit  
11h30  -  The key success factors for technology transfer
   
Frédéric GIRARD -SANOFI
PASTOR
 
12h00

- Transfers of sterile Lyophilized pharmaceutical products from a subcontractor.
Methodological approach and followed by critical parameters to optimize and
improved process reliability and lyophilization cycles
    
Jean-François MOYRAND - FAMAR

 
  12h30 - Feedback on the transfer of production of veterinary injectable
Carine ARCENS - Validapro
 
  13h00     Lunch  
  14h30 - Design of new equipment or improvement of existing equipment:
a key step to good process control
Sandrine FAVRE - OCTAPHARMA
 
  15h00  -  The integrated approach to validation of processes, a real opportunity for
better control of our processes?

    Baptiste BERRUEE - SANOFI PASTEUR
 
  15h30 - Comparability after-transfer process
Olivier DOUSSET & Céline BIES -NOVARTIS
 
        Break and exhibition visit  
  17h00 - The performance of the process on a parenteral multi-product production site
John Paul KACZMARCZYK - LILLY
 
  17h30 - Application of statistical process control on an industrial site 
Younes Hillali - GSK
 
  18h30   Cocktail & Dinner  
       
   
Wednesday February 03 2016
 
 
08h30

     
Participants registration and coffee
 
  09h00 - Establishment of an approach Extractable and leachable around a process
sterile liquid manufacturing
 

     
Baptiste CHESSE -Cenexi
 
  09h30   -  Presentation of the approach for monitoring of products on the site
Recipharm Kaysersberg

    
Jean-Philippe Pimmel & Matthew RUAS - ALCON / Recipharm
 
  10h00 - Capability of processes, an example of control of the dispersion volume
filling on an aseptic filling machine
 

     
Christophe Assire -ASPEN
 
  10h30      Break and exhibition visit  
  11h30 - How GSK Vaccines applies the principles of Quality By Design
to improve the reliability of its processes?
 

     
Marc PERE -GSK
 
12h00      Conclusion and outlook of these days A3P Process Control
 
  12h15      site visits, presentations LILLY & OCTAPHARMA  
  12h45      Lunch  
  14h00      bus departures Site Visits  
  18h00      Back at the Convention Center  
   

lilly logo logo octapharma
site lilly Site octapharma

PRESENTATION

Lilly US group operates in 73 countries and sells its medicines in 125 country. It employs almost 41 000 people in the world and spends over 20% of its turnover in R & D.

Lilly provides patients drugs in the areas of cancer, diabetes, neurological and psychiatric diseases, erectile disorders, osteoporosis, cardiovascular diseases and animal health.

THE SITE PRODUCTION FEGERSHEIM (Alsace)

Present in France since 1962, Lilly provides in Fegersheim in the Alsace region, the largest group of the production site for the production of injectable drugs. With almost 1500 employees, it provides 100 5 countries on continents. In 2014 he produced 189 million drug units (insulin, anti-cancer, growth hormone treatment of osteoporosis). 95% of this production was for export. For the same year, the site of Fegersheim recorded a turnover of 2,5 billion.

Visit
Visitors 5 divided into sub-groups may see the technical area production utilities and the new line of production of insulin in CGV3 insulator.

PRESENTATION

Octapharma develops, manufactures and commercializes medicines from plasma and recombinant therapeutic proteins to improve the quality of life and save lives.

Octapharma makes plasma-derived medicinal products for over 30 years to meet the needs of patients and the medical profession in the treatment of rare diseases and emergency medicine.
In accordance with French regulations (CSP) and in order to provide patients of drugs called "ethical" meet the standards, all of our MDS, marketed in France are from plasma collected from volunteer donors, volunteers and unpaid ( nor any financial compensation) in collection centers of the Red Cross (EU and USA), but not in France.
Octapharma continues its human and technological investments, including its plant in Lingolsheim, as well as its other production sites in Europe, such as Vienna and Stockholm, to meet the needs of patients and to support many European states (Luxembourg, Norway , Netherlands, ...) in their self-sufficiency program for MDS.

THE PRODUCTION SITE IN FRANCE "OCTAPHARMA LINGOLSHEIM" (Alsace)

The production site is located in Lingolsheim, and employs 450 employees. The Director General of the Site is Mrs. Fanny Chauvel.

Visit
The afternoon will begin with an interactive presentation of the production site to be followed by the visit of the process from the arrival of plasma to the aseptic filling and visual inspection (without decommissioned areas).



 

Nearby Hotels

Ibis Strasbourg Meinau ***
222 avenue de Colmar - 67100 STRASBOURG
Tel: (+ 33) 3 / 88403233
Mail: H6202@accor.com
 
Ceris Residences Strasbourg ***
Rue Job 5 - 67100 STRASBOURG
Tel: + 33 (0) 3 88 40 21 08
Mail: cerise.strasbourg@exhore.fr
 

Holiday Inn Express ***
Street of the rope - 67000 STRASBOURG
Tel: + 33 (0) 3 88 10 99 99

 
Hotel Diana Dauphine ***
30 Street 1ère the Army - 67000 STRASBOURG
Tel: + 33 (0) 3 88 36 26 61
Mail:
info@hotel-diana-dauphine.com


TRANSPORTATION


Public transport in Strasbourg : Http://www.cts-strasbourg.eu/fr/
Central Taxis Strasbourg : 03 88 122 122