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PRELIMINARY PROGRAM (subject to change)

Thursday, April 26:

FIRST SESSION

European environment and experiences about alternative microbiology methods.
Moderator: Didier MEYER, Getinge-La Calhène

> 9 h 30 - 10 h 00 Implementation of alternative methods in Europe within GMP's:
Microbiological qulity water monitoring and pharmaceutical product registration. Sylvie GUYOMARD, Sanofi Aventis, Expert Gr I and MMM Ph. Eur., France

> 10 h 00 - 10 h 30 Validation strategof alternative methods: Reference texts, interpretation and application. Benoît RAMOND, Sanofi Aventis, France

> 10 h 30 - 11 h 00 Break.

> 11 h 00 - 11 h 30 Implementation and validation of the laser scanning cytometry
for the control of sterile products. Dr. Gilberto DALMASO, QA Microbiology Laboratory Head, GlaxoSmithKline Manufacturing, Italy

> 11 h 30 - 12 h 00 Laser scanning and flow cytometry applied to the control of healthcare products. Yves CORTEZ, AFSSAPS, France

> 12 h 00 - 12 h 30 Discussion/Questions to the speakers.

> 12 h 00 - 14 h 00 Lunch at the Palais du Grand Large.

SECOND SESSION

American environment and experiences about alternative microbiology methods.
Moderator: Robert Johnson,Consultant, Dialogue

> 14 h 00 - 14 h 30 F.D.A and alternative methods: evolution, validations, trends. Jeanne Moldenhauer, PhD, Consultant, Vectech, USA

> 14 h 30 - 15 h 00 FDA approval of an alternate sterility test method for a sterile ophtalmic product. Gary GRESSET, Senior Manager, Corp. QA, Alcon, USA

> 15 h 00 - 15 h 30 Break

> 15 h 30 - 16 h 00 Development and adaptation of an isolator to carry out the preparatory
protocols for the control of sterile products by laser scanning cytometry. Didier MEYER , Director; Patrice Cloué, Director, Getinge-La Calhène, FRANCE

> 16 h 00 - 16 h 30 Solid phase cytometry for detection of bacterial contamination
in mammalian cells culture systems. Amy McDaniel, PhD, Associate Director, QC Microbiology Dept, Wyeth BioPharma, USA

> 16 h 30 - 17 h 00 Discussion/Questions to the speakers.

> 17 h 00 - 17 h 15 Conclusion.

> 19 h 00 Departure to the Cezembre Island to enjoy a typical “Corsair’s dinner”.

 

Third session: Friday April 27:

P.A.T. and environmental controls.
Moderator: Sylvie GUYOMARD, Sanofi - Aventis, France

9 h/9 h 15 Introduction

> 9 h 15 - 9 h 45 Process Analytical Technologies (PAT): a mircobiological perspective. Robert Johnson, PhD, Consultant, Dialogue

> 9 h 45 - 10 h 15 Mediasure®: new concept of Petri dishes for environmental samples and controls. Cyril MOUNIER, Internal Validation Engineer, Getinge-La Calhène, France

> 10 h 15 - 10 h 45 Break

> 10 h 45 - 11 h 15 Real-time detection of air contamination: comparative evaluation of the Polym’air®/Cytometry versus the traditional method. Stéphane GUYONNOT Sanofi - Aventis, France

> 11 h 15 - 11 h 45 Comparative Performance Study and Validation of a new Airborne
Contamination Monitoring Instrument. Agnès Bucher, Quality Control Manager, GSK Biological, Belgium

> 11 h 45 - 12 h 15 Discussion/Questions to the speakers.

> 12 h 15 - 12 h 30 Conference conclusion.

> 12 h 30 - 14 h 00 Lunch at the Palais du Grand Large.

> 14 h 15 - 18 h 00 Visit to the Mont Saint-Michel.

> 20 h 00 A.I.M.I.F. 2007 closing dinner.

FIRST SESSION

European environnment and experiences about alternative microbiology methods. Moderated by D. Meyer - Getinge-La Calhène