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logo congres2015 15 - 16 - 17 November 2016 - Biarritz
Conferences - Workshops - Exhibition

- Sterilization
- Single use
- regulatory

Each year almost 650 professional pharmaceutical and biotech industries meet in Biarritz to share their experiences et and explore the actual technical and scientific innovations.
3 themes were defined to guide the 2017 edition of the International Congress A3P: Sterilization, single use and regulation.

Congress a3p v2 

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Section EXHIBITION Form REGISTRATION
 

Congress Program A3P 2017
Congress Center - Espace Bellevue, Biarritz (France)nce

  Tuesday, November 15th
08h00 Welcome at the Bellevue
08h45 Introduction
Gérard Ecotière - A3P Association President
09h00 Provisions for vaccine availability
Philippe Juvin - Sanofi Pasteur
09h30

environmental risk analysis as a tool to meet the requirements of Chapters 3, 5 and 1 GMP Annex

Philippe Duhem - Intertek France
10h00

Analytical Quality by Design: the integration required for Quality by Designtradsimul
Isabelle Moineau - Aktehom & Véronique Chambon - Sanofi Pasteur

10h30 Break - Exhibition visit
11h30

Integrity Test Method for Helium: A case study on the development of a method for integrity testing of single-use systems using helium, integrated into a comprehensive strategy on the integrity of closed systems

Carole Langlois - Sartorius
12h00

Analysis of the impact of the changeover to the single use in a filtration process for the production of Allergens

Pascal Aouday - ALK
12h30

extractable Impact Assessment related to the use of disposable equipment

Alain Nonn- Lilly France
13h00 Lunch

14h30

connected medical device: what is the best technology to sterilize?
Chistophe Deneux - Becton Dickinson 

15h00

Final sterilization for pharmaceutical applications: development of innovative customized solutionstradsimul
Annick Gillet & Bart Croonenborghs - Sterigenics

15h30

Is hydrogen peroxide vapor decontamination process considered a sterilization process?

Antoine Akar - GSK Vaccines
16h00 Break - Exhibition visit
17h00 The Advantages and disadvantages of ready to use primary packaging material for aseptic filling - an overall comparisontradsimul
Daniel Kehl - Swissfillon AG
17h30 The use of single-use clinical insulator filling system
Franck Pavan - Amatsi Group
18h00 Feedback on 4 years of industrial exploitation of a biorpoduction workshop in disposable 
François Vanhersecke - Virbac
18h30 Welcome cocktail

 

    Wednesday, November 16th
08h30   Participants registration and coffee
09h00 Workshops first part (see list below to choose your workshop to return on your registration form)
10h30 Break / Exhibition visit
11h00  Resumption of workshops
12h30 cocktail buffet on show
14h00  Workshops second part
16h00   Break / Exhibition visit
16h30  Resumption of workshops
17h30  Workshops end
20h00   Gala dinner
   
    Workshops:
 N° 1

Serialization: an opportunity for CMOs and manufacturers of the drug?
Leaders Hervé Tassery
A3P Manager : Jean-Marc Libersa - Fareva &Nicolas Orange - Systech
abstract here

N° 2

Stability studies: understanding the most common problems and optimize protocols
Leaders : Pierre André
A3P Manager Emmanuel Billa- Cébiphar
abstract here

 N° 3

Aseptic Processes, how to respond to the remarks of inspectors in the context of the new Annex 1?
Leaders : Sophie Amadio
A3P Manager : Olivier Chancel - Merial & Walid El Azab - Steris
abstract here
 N° 4 Tools and tricks to take the time to stop for repairs
Leaders : Jonnathan Tafforin
A3P Manager : Nathalie Robineau - Institut Pasteur Dakar & Damien Poupry - Qualis Expertise

abstract here

N° 5 Pharmaceutical waters 4.0: the quality control for predictive maintenance
Leaders : Alain Rachon
A3P Manager Laurent Meurisse - Sanofi & Samah Ringa - Suez

abstract here 

N° 6
Come play with us and discover how you can optimize the performance of your cleaning / disinfection processes
Leaders : Anne Rigoulot
A3P Manager : Françoise Durand - Anios Laboratories & Benoît Ramond - Sanofi
abstract here
N° 7

Audits and inspections control laboratory
Leaders : Eric Petat
A3P Manager : Philippe Tivollier - TRB Chemi & Philippe Tailliez - ACM Pharma
abstract here

N° 8

Cleaning Validation: Application of Annex 15 European GMP manufacturer shaping a site of sterile products, non-sterile
Leaders : Isabelle Sarfati
A3P Manager : Ségolène Balls - Fareva Amboise & Pierre Devaux - UPS Consultants
abstract here
N° 9
English
Annex 15 / ASTM E2500: "Let's cross the bridge!"
GB chip web 01
Leaders : Patrick Hibon Frohen
A3P Manager : Stéphane Bertrand - Lilly & Maëlle Desreumaux - Assystem

abstract here 

 N° 10 A day of immersion in water, environment, quality and quality control, regulatory
Leaders : François Morel
A3P Manager : Jérôme Donon - A3P
abstract here
 N° 11
Data Integrity: how to evaluate your process at risk?
Leaders : Jean-Louis Jouve
A3P Manager : Hervé Cluzeaud - Assystem & Thierry Dufrasne - Baxter
abstract here
N° 12 Regulatory issues DM which a manufacturer is faced during the implementation of control testing or during the production and distribution of sterile media (bandages / dressings, for example)
Leaders : Didier Meyer
A3P Manager : Pierre-Jean Cavaroc - SGS

abstract here
N° 13
English
Sterile Installation Design to answer challenges nex Annex 1 1 EU GMP's Annex draft
GB chip web 01
Leaders : Vincent Griffoul
A3P Manager : Jean-François Dulière - ISPE France / Technip & Franck Lehle - Vetter

abstract here

 

  Thursday, November 17th
09h00 Welcome at the Bellevue
09h30

The sterility assurance, 10-6 to 10-3, what security we want?

Dominique Weill - DoWeLi Sarl
10h00 Open the field less conventional techniques in sterilization and initial bioburden reduction
Alain Euzen - Axys Network
10h30 Break - Exhibition visit
11h30

ICHQ3D (elemental impurities) an example of implementation in a subset pharmaceutical dealing (CMO: Contract Manufacturing Organizations)

Delphine Boivin & Marina Daubard - Excelvision
12h00

effective and affordable data management in a cGMP environmenttradsimul

Thierry Dufrasne - Baxter World Trade sprl
12h30

The revolution innovative therapy medicinal products (MTI): the challenges of pharmaceutical production and their consequences for health economics

Anne-Fialaire Legandre - EFS
13h00 Lunch and conclusion of the A3P Congress

 

Contact : Mylène RAT - Such. 04 37 28 30 40 - Mgarlic.This e-mail address is protected against spambots. You need JavaScript enabled to view it.

 

 

 

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