| Tuesday, October 20th 2009 |
| Hour |
Title |
Speaker |
|
| 09:00 |
Current revision of USP Chapter and the Future of Environmental Monitoring of Aseptic Production Environments |
James Akers - Akers Kennedy & Associates Inc. |
 |
| 09:30 |
An obligation for the producer and the shipper to identify his hazardous waste. |
Fabrice Bertolini - SITA France |
 |
| 10:00 |
Sensitives products during transport: What is the expectation of Agencies? |
Dominique David - Assystem |
 |
| 11:30 |
Q10 at work: towards Production Intelligence. |
Jeannette Ewen - Felten S.A. |
 |
| 12:00 |
Process compatibility of hydrogen peroxide vapour disinfection in Aseptic processing. |
James Drinkwater - Bioquell UK Ltd |
 |
| 12:30 |
Lyophilization Processes: Successful Scale-up. |
Enric JO - Reig Jofre Group |
 |
| 15:00 |
Sterile products manufacturers’ audits, inside & outside europe. |
Jean-Denis Mallet - CICR |
 |
| 15:30 |
Shared audits of suplliers, another way for the subcontracting of audits. |
Laurent Moreau - Intertek Sigma Contrôle |
 |
| 16:00 |
GMP Third Party audit: The SGS feedback over a period of one year. |
Marie-Cécile Krief - SGS ICS |
 |
| 17:30 |
Task Force Media Fill Test |
Stéphane Cousin - Schering Plough |
 |
| 18:00 |
Worst case justification of media fills conditions using the risk analysis. |
Alain Nonn - Lilly France |
 |
| Wednesday, October 21st 2009 |
| Hour |
Title |
Speaker |
|
| 09:00 |
Workshop 1 : Construction of a sampling plan for environmental monitoring and a methodology to manage deviations.(in French) |
Animateurs : Michel Combet, MC+ et François Guillou, Intertek |
 |
| 09:00 |
Workshop 2 : Filling line under isolator : process, storage, transfer and use of closures. (in french) |
Animateurs : Dominique Sierakowski, Octapharma et Brigitte Lechiffre, Getinge La Calhene |
 |
| 09:00 |
Workshop 3 : How to combine sustanability and Disposable technology. (in french) |
Animateurs : Thomas Bijou, EFC Solutions Packaging et Sébastien Leyendecker, Millipore |
 |
| 09:00 |
Workshop 4 : Integrated Commissioning and Qualification-approach. (In french) |
Animateurs : Olivier Surieux et Grégory Mauduit, SPIE Sciences de la Vie |
 |
| 09:00 |
Workshop 5 : Control of microbiological contamination in a water loop from the design to daily operations. (in french) |
Animateurs : Samah Ringa, BWT Permo et Eric Petat, ACM Pharma |
 |
| 09:00 |
Workshop 6 : Sub-contactors and generics producer : economical competitiveness and reinforcement of the regulation. (in french) |
Animateurs : Alain Richard, AFSSAPS et Thierry Depauw, Excelvision (Groupe Fareva) |
 |
| 09:00 |
Workshop 7 : API Quality for Parenterals production. (in french) |
Animateurs : Emmanuel Pâques, Nextpharma ; Lionel Viornery et Abdelaali Sarakha, AFSSAPS |
 |
| 09:00 |
Workshop 8 : Training on the floor shop : from theory to practice on the field. (in french) |
Animateurs : Stéphane Cousin, Schering Plough et Patricia Jamoulle, GMP |
 |
| 09:00 |
Workshop 9 : Classify your computerized systems according 21 CFR part 11 requirements. (in french) |
Animateurs : Olivier Corriger et Nathalie Romanet-Robineau, Récipharm Monts |
 |
| 09:00 |
Workshop 10 : How to qualify retrospectively an equipment restarted, revamped or bought-in second-hand ? (in english) |
Animateurs : Thomas Pothier, Récipharm Monts et Malke Luetgens, Valicare Gmbh |
 |
| 09:00 |
Workshop 11 : Highly purified water for pharmaceuticals, cosmetics, medical engineering or move towards excellence and very high security. (in french) |
Animateurs : Henry Lérat, H. Burkhalter et Frédérique Le Bouquin, Véolia Water STI |
 |
| Thursday, October 22nd 2009 |
| Hour |
Title |
Speaker |
|
| 09:30 |
An industrial process for the preparation of an innovation product: drug encapsulated in red blood. |
Arnaud Faivre - Erytech Pharma |
 |
| 10:00 |
Automated Control and Identification of Foreign Particulate Matter. |
Jean-Sébastien Bonin - PMT France |
 |
| 11:30 |
Handling of highly potent drugs: risk analysis. |
Emmanuel Pâques - Nextpharma |
 |
| 12:00 |
Management of the production installations corrective actions (GMP compliance). |
Badrig Baghdikian - Air Consult Engineering |
 |
| 12:30 |
Outsourcing of injectable drugs. |
Sovannary Gosse - AFSSAPS |
 |
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