Circu MED INTERNISTES ETC.qxd

Biarritz, France, October
19th, 20th and 21st, 2010
Simultaneous translation French/ English
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A3P Formation - 22, rue Aristide Briand - 45220 Château-Renard - France
Tél : 02 38 071 071 - Fax : 02 38 071 072 - E-mail : [email protected]
Keynote from the President
Dear friends
On October 19th, 20th and 21st, our 23rd Congress will be held as usual in Biarritz.
I have the pleasure to send you the program:
- 15 lectures will assure the sessions of communication,
- 11 workshops of 1 day will allow you to work and to exchange on technological
concrete topics of the Clean and Sterile environment
- 90 suppliers will compose the exhibition, allowing you to be informed on new
equipments and technologies,
The operations of hotel booking “B&B” and coffee break “C&C” which facilitated your life last
year are renewed
According to our reputation the gala evening will reflect the conviviality and dynamism of the
Association,
Dear friends, we wait for you in October in Biarritz with great pleasure.
G. ECOTIERE
A3P President
More about the Congress on
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www.a3p.org
Tuesday, October 19th
Lectures
All the lectures are located in the Bellevue Congress Hall.
8h00
Welcome to the participants at the Bellevue Space
8h45
Word of the President
9h00
New development in vaccines and administration routes
François Dalençon - Sanofi Pasteur
9h30
Acceptance Criteria in the Validation of Isolator Decontamination
Jim Akers - Akers Kennedy & Associates, Inc.
10h00 Hospital healthcare workers (physician and pharmacist) exceptations from Pharmaceutical Industry
Professeur Denis Brossard - Faculté de Pharmacie de Paris
10h30 Break - Visit of the Exhibition
11h30 Machinability of gamma irradiated PFS plungers
Pierre Poulain - Stelmi
12h00 Comparative analysis between commissioning methodology for the pharmaceuticals and
Oil & Gas industry
Philippe Billaud - SNC-Lavalin
12h30 H2O2 decontamination: From cycle development to production cycle
Christian Doriath - Lilly
13h00 Lunch
15h00 Biotech Companies: Are they the future of drug discovery and development?
Olivier Litzka - Edmond de Rothschild - Investment Partners
15h30 Clinical trial solutions, disposable filling systems and new package styles for Biotechnologies injectables
Damien Cheynet - Robert Bosch
16h00 Decision factors for single-use technologies in the formulation of clinical batches
Claude Simon - Sanofi Aventis
16h30 Break - Visit of the Exhibition
17h30 Simulation and quantification of air flows by use of the CFD (Computational Fluid Dynamics)
Beat Lorenz - Debiopharm Group
18h00 Integrated solution for clean and sterile pharmaceutical glass containers ready to be filled
Paolo Golfetto - Stevanato Group
18h30 Exhibitors Cocktail
19h00 Annual General Meeting of the Association
www.a3p.org
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Wednesday october 20th
Workshop day
All the workshops are located in the Bellevue Congress Hall.
8h30
Welcome of the participants at the Bellevue Hall - Biarritz (France)
9h00
1st part of workshops
Choose your workshop from the following list and report your choice on the registration from page 11.
10h30
Coffee / Visit of the exhibition hall / Poster session
12h30
Lunch
14h00
2nd part of workshops
16h00
Coffee / Visit of the exhibition hall / Poster session
17h30
End of the workshops and the 22nd Congress
20h00
Gala Dinner
List of Workshops to choose from: The workshops are provided without silmutaneous translation
WORKSHOP N°1 (in french)
Management of non conformity from subcontractors or suppliers of Active Principles
A3P Representative: Frédéric Laban
Moderators: Ali Sarakha - AFSSAPS and Muriel Boulade - Pierre Fabre
During the arisen of a non conformity from subcontractors or suppliers of Active Principles , several mechanisms bustle. Through a work of reflection and exchanges between
industrials and representatives of the French agency of drug ( AFSSAPS) and from concrete exercises, finalizing elements of strategy for the management of the nonconformity
from subcontractors or suppliers of Active Principles.
WORKSHOP N°2 (in french)
Management of the anti counterfeiting systems
A3P Representative: José Blairon
Moderators: Christine Tholomé – GSK Biologicals and Alain Foucou – Advanced Track and Trace (ATT)
The counterfeiting is a real pest in the world mainly for the drug market involving the public health. That counterfeiting market advances quickly and more than 10 % of the
drugs delivered worldwide are concerned. The counterfeiting may be a real threat for the patients but also for the financial wellbeing and the reputation of the Pharmaceutical
Industry That market is developing quickly having a great effect on the total volume of the drugs shared out worldwide. The counterfeiting constitutes a threat for the human
but also for the financial health and the reputation of the pharmaceuticals companies. As an answer the Phamaceutical Industry put in place security systems in agreement
with the different regulations keeping the productivity and the cost at an acceptable level. That system must warrant the integrity and the authenticity of the medicine up to
the patient. The objective of our workshop is the highlight the critical aspect of that phenomenon and to give you the technical solutions used for estimate, trace and
authentify the pharmaceutical products. We will start with a review of some theoretical and technical aspects before pass on to the practical application in a packaging unit
showing the issues and the challenges the companies have to face. Finally, a demonstration of the Advanced Track and Trace system and the application on real case will
be presented you. That workshop will be interesting for Production persons as well as Engineering, Quality and Commercial representatives. So, exchange of experiences
concerning the counterfeiting would be interesting to have.
WORKSHOP N°3 (in french)
Permanent Inspection Readiness (PIR)!
A3P Representative: Thierry Wermelinger
Moderators: Anthony Liziard - MERCK Manufacturing Division and Alain Richard - AFSSAPS
This workshop will study concrete cases describing what it is necessary to set up in a company so that an inspection is lived as a “common” event and either as an important
risk.
The following themes will be approached:
- Quality by design
- Definition of the systems
- Appropriation of the Quality systems and the other systems of the company (production, logistics, maintenance, engineering)
- Management of processes, governance
- Evolution of the Quality systems – Risk analysis
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www.a3p.org
Wednesday october 20th
Workshop day
WORKSHOP N°4 (in french)
Validation of computarized system for non specialist
A3P Representative: Hervé Tassery
Moderators: José Sanchez - INTERTEK and Cécile Debard - ROOWIN
As non specialist in Validation of computerized system, the participants will see how to take part in the conception and/or understanding of specifications for a computerized
system to be validated.
They will search what is necessary to be precised into a design qualification: the good questions to be asked, the technical elements to be specified which will be exploited
at different steps of qualification of the system, they will identify the critical points to be qualified on an automatized / computerized system: Which points? Why? How?
The participants will work on concrete examples: LIMS / GPAO.
They will search and identify elements allowing to the user to guarantee an assertion of system in validated status.
WORKSHOP N°5 (in french)
Pharmaceutical purified water delivery loop, and its microbiological contamination
complete mastery
A3P Representative: Monique Decrulle
Moderators: Henry Lérat - HEINZ BURKHALTER and Samah Ringa - BWT PERMO
Workshop’s participants have to study a delivery loop fed with purified water, from its design to its use, including also some bacteriological contamination problems.
The main purpose is to learn their best design, microbiological pollution, preventive contamination methods and disinfection process. Pharmaceutical purified, high purified
and distilled waters are defined according to very accurate rules included in Eu.Pharmacopeia and USP.
Pharmaceutical purified water is one among main raw materials.
Various purified, high purified and so on waters plants will be introduced and explained, with comparison between old standard process and brand new non polluting
methods. Main biological contamination reasons will be presented and debated.
During this workshop the listeners will study some delivery loops infected and will present some solutions.
Their studies will be analyzed, explained and corrected (if it is necessary).
WORKSHOP N°6 (in french)
ICH Q8 integration in design and equipment testing: autoclave case study
A3P Representative: Sophie Amadio
Moderators: Etienne Hembert and Dominique Diss - LILLY
Periodic revalidation, which was historical reserved to sterilization systems, is gradually applied to cleaning systems, sorting processes …
The resources dedicated to revalidation are continually increasing. Meanwhile, the initial validation workload is also increasing (design qualification, risk analysis, performance
qualification including all measurements tolerances…)
At this stage, is it possible to determine a level of initial validation that could allow discontinuing periodic revalidation?
The workshop proposes to work on a specific case study: an Autoclave.
WORKSHOP N°7 (in french)
Conception and validation of the single-use systems in the processes of
manufacturing pharmaceutical
A3P Representative: Dominique Sierakowski
Moderators: Luc Dubois - VALIDAPRO and Marie-Pierre Travers - PALL
The workshop is organized in 3 phases: the first part will be dedicated to a fast reminder of the single-use devices available on the market and their advantages.
In the second part,the participants, distributed in subgroups will approach three subjects from concrete cases which will be treated in parallel by three subgroups, Costs
and deadlines and management of the waste of a single-use system with regard to a reusable system. Conception of the single-use systems with the choice of various
constituents Validation in order to encircle what is really required. We will develop particularly aspects such as extractible/relargable and the sterilization of these systems,
what the manufacturer has to realize and what the supplier can and has to supply.
The participants will have examples of various systems for applications from which they can develop these subjects.
This workshop will allow to share experience on single-use either mixed complex systems.
In conclusion, a synthesis of the work of the subgroups will be presented.
www.a3p.org
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Wednesday october 20th
Workshop day
WORKSHOP N°8 (in french)
Modular or regular building? Are the pharmaceutical modules new ready to be used
in place of regular infrastructures?
A3P Representative: Nathalie Robineau
Moderators: Michel Daunes - IPM and Lionel Boutrou - INGÉCENTRE
The workshop will be done around User Requirement Specifications for the implementation of a new aseptic filling area for vials. This area will have washing machine, tunnel,
filling line and capping.
Target of the day will be to compare the answer to the URS between the 2 options. Each group of attendees will work on one of the 2 options and the results will be
compared as exhaustively as possible.
Comparisons will be done on several items as: Number of suppliers, Leadtimes, Resources, Costs, Qualification, Decisions to make, etc.
WORKSHOP N°9 (in english)
Quality by Design and Risk Assessment and Abatement in Aseptic Processing
A3P Representative: Didier Meyer
Moderators: Jim Akers - AKERS KENNEDY & ASSOCIATES et Alain Nonn - LILLY
Questions to be considered:
- How can modern regulatory initiatives such as QbD and Risk Management by most efficiently and effectively applied toward the design and validation of aseptic processing
operations?
- Can these more recently defined activities be integrated into more traditional validation efforts and if so how?
- What is the most effective way to apply risk assessment and abatement in aseptic processing?
How should firms be responding to these challenges and what effects might they have on technology assessment, project management and corporate organization.
ATELIER N°10 (in french)
To organize scope and schedule of a validation program
A3P Representative: Alain Rachon
Moderators: Michel Combet - Patriarche MC+ and Isabelle Pautre - GENETHON
The first part of the workshop will summarise the different steps of a qualification program including VMP, critical analysis, Design Qualification and Change Control, until
the detail of tests to perform.
Analysis of requirement for each system will give the route to organize the sequence of tests and the planning.
Based on several examples, participants will set up and justify:
- Protocols of tests for facilities and utilities
- Sequence of tests execution
- Means to reduce duration of qualification program.
WORKSHOP N°11 (in french)
More than a guide for audit of primary packaging manufacturers: ISO 15378 Standard
A3P Representative: Jérôme Donon
Moderators: Vincent Langlade - SGD and Jean-Francois Monconduit - STELMI
Pharmaceutical primary packaging items must be treated with the same care as excipients. They are a vital link for the proper conservation of the drug. The auditors of
pharmaceutical company do not always know which reference audit guide use. The ISO15378 standard of August 2006 is the reference guide of choice. After having evoked
the genesis of the standard and its architecture, the workshop participants provided with their personal copy of the standard will deal with the development of an audit grid but
also with the following point: Conduct a comparative risk analysis between the use of a subcontractor for the manufacturing of primary packaging operations, which are
theoretically of the pharmaceutical responsibility and performing these operations within the pharmaceutical structure.
Thus the advantages and the disadvantages will be determined and this from a quality point of view but also economically or environmentally. The following examples could be
treated:
• Glass vials for injection or not.
• Lyo vial stoppers or syringe injection.
According to studies carried out for the point above, the group will develop a method for a delegation of control or also for a retained samples area from the manufacturer of
packaging items.
Conclusions will be brought to the day, highlightin.
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www.a3p.org
Thursday, October 21st
Lectures
All the lectures are located in the Bellevue Congress Hall.
8h00
Welcome to the participants at the Bellevue Space
9h30
Contribution of the very high resolution microscopy to pharmaceutical industry
Tauno Jalanti - Microscan Service SA
10h00 Methods of radiation sterilisation
Conrad Guenthard - Leoni Studer Hard AG
10h30 Break - Visit Exhibition
11h30 how to conceive a system of long-lasting water treatment for the Environment
Johann Bonnet - Veolia Water Solutions & Technologies
12h00 Articulation between the appendix 1 of the BPF and the harmonized Standards in the sterilization of the
DM by ethylene oxide
François Bruneaux - AFSSAPS
12h30 Lunch and Quiz Results
14h30 Round table AFSSAPS / A3P:
New requirements of the appendix 1 of the GMP: expectations of the Inspection.
This theme will be developped during three interventions; one of the AFSSAPS, One of A3P and one of the participants who
will have the opportunity to ask their Questions either in writing on forms provided to them the First days of the Congress, or
by their direct questions after presentations.
This round Table animated by Olivier Ribes and Jacques Nicolaï of the French Agency for the Safety of Health Products and
representatives of A3P will allow an exchange of points of view and experiences whom purpose is to allow everyone to
improve its Knowledge of the subject and to build up its own opinion about the expectations of the Inspection in its company
16h00 Congress high spots movie
www.a3p.org
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Comme Pierre, prévoyez de passer sur le stand 83
pour discuter avec nous de vos projets en Assurance Qualité
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De Valck Consultants est la marque Assurance Qualité dédiée aux Sciences de la Vie du groupe Altran, leader européen en innovation
Exhibition
During the Congress, the exhibition is a real opportunity that facilitates exchanges between customers and suppliers.
Few booth are still available; to book one of them, contact us at 33(2) 38 071 071 or download the exhibition file on our web site : www.a3p.org.
AAF
ACM
AERIAL
AMILABO
ARECO
bioMERIEUX
BIOQUELL
BIOTEST
BWT PERMO
CABINET MOREL
CHARLES RIVER
COMECER
CONFARMA
3 M CUNO FILTRATION
DE VALCK CONSULTANTS
DIVERSEY
ENNOV
ERMAFLUX
EUROFINS PHARMA CONTROL
GARLOCK
GERFLOR
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GETINGE
GRONINGER & CO Gmbh
HACH LANGE
IMA LIFE
INITIAL BTB SAS
INTERTEK
JCE BIOTECHNOLOGY
KIMO INSTRUMENTS
LABORATOIRES ANIOS
LABWARE
LAPORTE EXPERTS CONSEILS
LEBAS TECHNOLOGIES
LONZA
MILLIPORE
NNE PHARMAPLAN
NUOVA OMPI SRL UNIPERSONALE
OPTIMA GROUP PHARMA
PALL LIFE SCIENCES
PAMAS
PARKER HANNIFIN France
PHARMADEC
www.a3p.org
PIERRE FABRE MEDICAMENT PRODUCTION
QUALISTE VALIDATION SERVICES
ROBERT BOSCH
SCHREINER MEDIPHARM
SCHULKE France
SGS LIFE SCIENCE SERVICES
SHIELD MEDICARE
SKAN AG
SNDI ELIS
SPC France
SPIE OIL &GAS SERVICES
STELMI
STERIGENE
STERIS SA
SYMBIOSE ENVIRONNEMENT
TESTO
VALIDATOOL
VEOLIA WATER STI
.../...
A3P has selected different hotels.
Best terms have been negociated by A3P, included room and breakfast.
Find the reservation file on www.a3p.org with the selected hotels.
We built a partnership with «Tourisme Basque» which will help you with
your booking ; the partner Agency will be pleased to advise you on your
choise.
24, avenue Foch – 64200 Biarritz
Tel: +33 (0)5 59 24 01 10 - Fax: +33 (0)5 59 26 18 82 - Mail: [email protected]
Hautes exigences?
Sécurité jusque dans le moindre détail.
La voie la plus sûre et la plus rapide qu‘un nouveau produit puisse emprûnter:
les technologies de remplissage et de conditionnement d‘OPTIMA GROUP pharma.
Un lancement rapide après l‘autorisation de mise sur le marché est une garantie de succés. Les
marques inova, Kugler et Klee offrent une gamme hors pair de machines pour le remplissage,
le conditionnement et la lyophilisation pharmaceutiques, y compris les processus en amont
et en aval, jusqu‘aux logiciels d‘automatisation. L‘ensemble des machines répondent aux plus
hautes exigences en ce qui concerne la sécurité du processus, autant que question rendement
et flexibilité.
OPTIMA GROUP pharma GmbH, Otto-Hahn-Str. 1, 74523 Schwäbisch Hall, Germany, www.optima-group-pharma.com
OPTIMA packaging France S.A.R.L, 4, rue Ampère B.P. 9, 59559 COMINES Cedex - France, www.optima-fra.com
Optima Group dans le monde entier: USA, Mexique, Brésil, France, Angleterre, Italie, Japon, Corée, Chine et Allemagne.
www.a3p.org
INOVA
KUGLER
KLEE
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Registration form
Mr
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23rd A3P Congress - 19th, 20th, 21st October 2010 - Biarritz
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