International Congress 1263
International Congress 1263
International Congress 1263
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16 Lectures 11 Workshops
Exhibition Round table
A3P
Services
22, Rue Aristide Briand
www.a3p.org
Editorial
Sterility Assurance, a permanent concern!
Endless topic is the STERILITY ASSURANCE, subject that will gather the 2013
participants to the A3P 26th congress in Biarritz, along with the SINGLE USE
SYSTEMS and COMBINATION PRODUCTS, the whole being today more and more
frequently associated for the administration of treatments sometime complex. The
presentations will put these topics into perspective, with their practical aspects
which are daily questioning all contributors of the production chain. They are always
looking for improvements and innovations made possible by the evolution and
development of new technologies; they force us to reopen the basics of current
practices, what is really understood, but most and foremost what remains essential, in order to envisage
the evolutions around these practices, all to the service to the patient. Experts will share their experience
and potential perspectives.
The round table will discuss these questions in a structured manner, to review current thinking and
evaluate the conditions to fulll for the promotion of these evolutions, never forgetting that Sterility has
only for good Company the Assurance that supports it!
Biarritz 2013
Lectures
8h45
8h50
Opening lecture
Patrick Turlier - GSK
9h00
9h30
www.a3p.org
Workshops
Wednesday October 16th
All the workshops are located in the Bellevue Hall.
8h30 Welcome to the particpants 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 Break - Visit of the exhibition
12h30 Lunch
14h00 2nd part of workshops
16h00 Break - Visit of the exhibition
17h30 End of the workshops
20h00 Exclusive and unique Gala Dinner
List of workshops to choose from: The workshops are provided without simultaneous translation.
WORKSHOP N1 (in french)
HOP
ORKS
PLETE W
COM
Biarritz 2013
Workshops
Bacterial and viral biofilms prevent from production and preservation of germ free
water. These bacterial and viral communities are genuine biological fortress,
bactericidal and virucidalproof. In order to obtain pharmaceutical pure waters,
protected against exogenous contaminations, specific water treatment production
systems and devices are introduced with additional instructions.
A3P Representative: Arnaud Carlotti
Moderators: Henry Lerat - Burkhalter AG et Frdrique Le Bouquin - Veolia Water France
Biofilms
1-a) well study their development (from birth to lysis). First particles adhesion growth glycocalyx forming ripeness and lysis. Well study also bacterial ADN
as glycocalyx reinforcement agent.
1-b) Viral biofilm: specific analysis
2) Work shop. The participants in work shop conceive a biofilm free plant and biofilm free purified water loop from their knowledge.
3) Remedy. Well study participants solutions. Well introduce our own solutions pertaining to biofilm free purified water plant biofilm free purified water (liquid
storage plant and loop).
4) Well introduce specific process to preserve production shop devices from biofilms contamination.
www.a3p.org
Workshops
Wednesday October 16th
WORKSHOP N7 (in french)
Daily Risk Management: From identification to follow up and review on EHS / Quality
& Business risks in vaccines production
A3P Representative: Roland Guinet
Moderators: Antoine Maximillien et Francis Leclercq - GSK Saint Amand
The workshop on Daily Risk Management will address several aspects:
Identification of Business / EHS & Quality risks from an example about vaccines processes.
Assessment: the formalization and the way to proritize will be treated, with risks identified from the example and the method to calculate their score
Remedial actions: root cause analysis tools will be used in order to identify the appropriate actions to be implemented with for example, root cause analysis
methodology and the tool 5 why.
Follow up and review: examples of operational management tools such as Risk register and Key Performance Indicators (KPIs) will be developed.
Biarritz 2013
Workshops
www.lighthouseinstruments.com
www.a3p.org
Lectures
Thursday October 17th
8h00
9h00
Process development and manufacturing: Single Use versus Glass and Stainless Steel
Laure Valognes - Merck Biodevelopment
9h30
Innovative raw material management and product design strategy for enhanced quality, assurance
of supply, validation & change control of single use systems
Jean-Marc Cappia - Sartorius Stedim Biotech
10h00 Single-use: the right choice for Fill & Finish applications?
Florelle Tourlet - Octapharma
10h30 Break - Visit of the Exhibition
11h30 New regulatory framework for Cell and Gene Therapy
Isabelle Pautrel - CELLforCURE - Groupe LFB
12h00 Control criteria of class A/B for lling processes with terminal sterilisation
Julien Triquet - GSK
12h30 Lunch
14h00
ROUND TABLE:
Systems Ready To Use (RTU) / Single Use (SUS) for aseptic processes: what are the consequences for the product quality (particles,
leachables, relargables, others) and on sterility assurance (verication of the integrity of sterilized materials at the point of use) ?
Modication of Annex 1: the last version dated 2008 includes some
points to correct and some others to better explain. New requirements could also probably be proposed in order to include all current
aspects.
Under the supervision of Jacques Navellou (A3P) each topic will be discussed during around one
hour after a short introduction indicating some pending questions (Roland Guinet, RGmp
Compliance, A3P). The discussion will include experts on each topic either end users, speakers or
workshop leaders at the congress or ex members of NRA. The possible experts include for RTU:SUS
Dominique Sierakowski (Octapharma, A3P), Anne Rigoulot (sano pasteur, A3P) et Georg Roessling
(PDA Europe) and for the revision of Annex 1 Jean-Denis Mallet (NNE Pharmaplan), Patrick Turlier
(GSK, LEEM quality leader, A3P) and Frdric Laban (Laban Consultants). You will be able to raise
any question either during the discussion or by communicating to the Organising Comitee before
the round table.
Congrss A3P
Congr
Biarritz - 2012
915 visites
de
congressistes
MAN
MANIFESTATION
IFESTATION
84
exposants
d'expositions
INTER
INTERNATIONALE
NATIONALE
Biarritz 2013
Exhibition
Its still possible to take part as an exhibitor, please contact Sophie Cornu at 33(2) 38071071 or on scornu@a3pservices.com.
EXHIBITORS LIST TO DATE:
C4
C5
C6 C7
C8 C9
63
56
50
37
105
41
83
116
51-52
42
34
ERMAFLUX
36
EUROFINS
32
FURNESS CONTROLS
9
GE MEASUREMENT & CONTROL
55
GEA LYOPHIL
44
GERFLOR
30
GETINGE
107
GRONINGER & CO
11
ICARE
64
IMA France
112
INENTECH
46
INITIAL SAS
45
INTERTEK
85
JB TECNICS-Groupe JBT
C1
JCE BIOTECHNOLOGY
100-101
KIMO
31
LABORATOIRES ANIOS
15
LABWARE
118
LAPORTE EURO
114
LIGHTHOUSE INSTRUMENTS
65
LONZA
94
MERCK MILLIPORE
17-18
METTLER TOLEDO ANALYSE INDUSTRIELLE 61
MICROSCAN SERVICE
117
MRB Automatismes Industriels
C7
NNE PHARMAPLAN
104
NOVATEK INTERNATIONAL
C3
OPTIMA PACKAGING France
95
PALL LIFE SCIENCES
60-90
PAMAS
14
PARKER HANNIFIN
7
106
Kiosque 10
C8
67
111
92-93
33
88-89
C4
66
20
91
102-103
43
86
13
16
5
109
C10
104
C2
C1
116 117
103
115 114
102
101
98
70
107
69
PLUMAT
96
PMT France
40
19
ROMMELAG AG
54
SAPIC
C11
SCHOTT AG
97
SCHREINER MEDIPHARM
98
SCHULKE France
84
99
SHIELD SCIENTIFIC
35
SKAN AG
12
SNDI ELIS
68-82
SOPAC
STERIGENE
69-70
STERILINE
10
STERIS SA
C5-C6
SWAN
113
SYMBIOSE ENVIRONNEMENT
110
TECHNIP
62
TELSTAR
87
VAISALA
115
71
WILCO AG
C2
...
97
96
95
94
93
92
91
100
82
83
84
85
86
87
88
89
90
68
67
66
65
64
63
62
61
60
108
71
50
51
52
53
54
55
56
40
41
42
43
44
45
46
30
31
32
33
34
35
36
17
18
37
RIA
109
16
19
110
1
15
111
112
105
106
C9-C10
STAND RSERV
Occupied
space
99
118
53
PIERCAN
Exhibition map
Free
STANDspace
LIBRE
C11
C3
PHARMTEC
7 9
113
5
10
11
12
20
5
4 6
8
13
10
14
www.a3p.org
ACCUEIL
5M PARTNER
AAF
ACM PHARMA
AFTON SCIENTIFIC
ALTRAN
AMILABO
APTAR STELMI
ARECO
ASSOCIATE OF CAPE COD
AWEL INTERNATIONAL
BATIMPRO
BAUSCH ADVANCED TECHNOLOGY
GROUP-BAUSCH SWITZERLAND
BCMI Guide de l'Ultra Proprete
BECTON DICKINSON
BELIMED
BIION
BIOMERIEUX
BIOPRACTIS TRAINING CENTER
BIOQUELL
BLEZAT
BRUNO COURTOIS SA
BURKERT CONTROMATIC SAS
BWT PERMO
CHARLES RIVERS
COFELY AXIMA
COMECER
CONFARMA
CONTEC INC
DISPOSABLE LAB
ENNOV
Appointments
The biennial meeting of microbiology. The "Workshops" organized with the partner
companies will review various existing alternative techniques and present several devices.
Conferences - Workshops - Exhibition.
March
Second year around the Freeze drying with a refund of the work of the A3P Interest Group
(CIG A3P) and always a visit of a production site.
Conferences - Workshops - Round Table - Exhibition.
April
June
nd
July
14th to 16th
October
2014!
P
R
E
S
S
PA RT N E R S
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Registration form
Mr
Ms ..............................................................................................................................................
Company .................................................................................................................................................
VAT number .............................................................................................................................................
Job Title ...................................................................................................................................................
Adress .....................................................................................................................................................
Coordinates
Tariffs
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Payment
TOTAL :
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Signature
To be returned with your paiement taxes included to A3P Services - inscriptions congrs A3P - 22, rue Aristide Briand - 45220 Chteau-Renard - France
e-mail : info@a3pservices.com - Tl. +33 (0)2.38.071.071 - Fax. +33 (0)2.38.071.072
In case of cancellation received by fax or by mail, 50% of the registration will be retained and the full amount one month before the event.
www.a3p.org 11
altafulla - Shutterstock
altran.com
Note in your agenda for your french speaking people and partners some training sessions !
17 septembre 2013
Comment btir
un programme de
bio-nettoyage
des Salles Propres en
environnement GMP ?
Dvelopper
ses connaissances
dans le domaine
de la lyophilisation
Animateur :
Frdric Laban
Laban Consultants
Lieu : Novotel Paris Bercy
Dure : 1 journe (8h30 - 17h30)
Animateur :
Dominique Sierakowski
Octapharma
Lieu : Novotel Paris Bercy
Dure : 2 jours (8h30 - 17h30)
Animateurs :
Frdric Laban - Laban Consultants
Roland Guinet - RGmp Compliance
Lieu : Novotel Lyon La Part Dieu
Dure : 2 jours (8h30 - 17h30)
Pour plus dinformations : A3P Formation - Tl. +33 (0)2 38 071 071 - E-mail : a3pformation@a3pservices.com - www.a3p.org
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www.a3p.org