A3P Forum in Italy
Microbiology

Place

Enterprise hotel

Milan

Dates:

25 and 26 September 2019

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Format

Conferences, interactive workshops, exhibition

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The A3P Italy Committee, having studied all possible alternatives and scenarios in which industrial microbiology is based, proposes two days to have an updated overview of pharmaceutical microbiology.
The goal we set, with all stakeholders, is to provide practical tools to manage the problems that "afflict" everyday people living in microbiology.
A first important contribution from the academic world will be devoted to industrial microbiology and how it has differentiated and evolved in relation to clinical microbiology. In collaboration with industry experts, we will present the inspection / regulatory perspective to highlight key trends in contexts that are not always easy to interpret.
A moment of confrontation, the latter, through which we will attempt to address all these issues that are an integral part of the daily activities of the laboratory.
We will try to give a complete picture of the processes involved in sterile tests with a particular focus on the concept of performance and a vision towards the compendiums of the future.
We will talk about biotechnology by carefully examining how microbiology is, in this context, an all but obvious subject.

We will deal with an issue that is far from obvious and concerns mycology with indications of what the risk factors in the industrial field might be.

We will spend the second day responding to the need for process efficiency by applying fast microbiological methods as an alternative to traditional methods.
Special attention that will begin with a contribution in the field of inspection, in which we will clarify the regulatory requirements to be respected and understand how the regulatory environment evolves.
We will propose targeted interventions on microbiological contamination control strategy and environmental monitoring; we will illustrate the peculiarities of insulator production and the management of associated sampling activities.
With regard to pharmacopoeial monographs (USP and EP), will we compare fast microbiological methods, which will be complementary or alternative to conventional microbiological approaches?
We will conclude with two topical issues such as risk management and data integrity.
Interactive reports and workshops on the different topics will alternate so that participants can "touch" all that is today industrial pharmaceutical microbiology.

Wednesday 25 September 2019

Italian will be the official language of the event (simultaneous translation in English)

Welcome of participants
08:15
Introduction
08:50
Clinical microbiology and industrial microbiology: what are the limits? What promises?
Lorenzo DRAGO - UNIVERSITY MILANO
9:00
The situation of inspection today: overview of drug production and API
Fernanda FERRAZIN - Life Sciences Sector Expert
9:30
Coffee break - Visit of the exhibition
10:30
Microbiology and sterility tests: today's performance, the pharmacopoeias of tomorrow
Felix MONTERO - bioMérieux
11:00
Interactive workshops
ARCHILEX // ASSOCIATES OF CAPE COD // BIOMÉRIEUX // CHARLES RIVER
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
11:45
Lunch - Visit of the exhibition
12:45
Interactive workshops
ARCHILEX // ASSOCIATES OF CAPE COD // BIOMÉRIEUX // CHARLES RIVER
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
14:00
Coffee break - Visit of the exhibition
15:00
Innovative Therapy Drugs and Sterility Assurance
MariaLuisa NOLLI - NCNbio
15:30
Mycology and risk factors: what are the effects on the industry?
Marinella RODOLFI - University of Pavia
16:15
End of the day and networking cocktail
17:00

Thursday 26 September 2019

Italian will be the official language of the event (simultaneous translation in English)

Welcome of participants
08:15
Introduction
08:50
Rapid microbiology: which regulatory scenarios?
Fernanda FERRAZIN - Life Sciences Sector Expert
9:00
Contamination Control Strategy: Focus on Environmental Monitoring
Gilberto DALMASO - PARTICLE MEASURING SYSTEMS
9:45
Coffee break - Visit of the exhibition
10:15
Workflow and rapid microbiology ... focus on isolator production
James DRINKWATER - Ziel GmbH & Chairman of PHSS
10:45
Interactive workshops
ARCHILEX // ASSOCIATES OF CAPE COD // BIOMÉRIEUX // CHARLES RIVER
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
11:15
Lunch - Visit of the exhibition
12:15
Rapid microbiology and product design: what considerations?
Vincenzo ROSSI - Haupt Pharma
13:30
Interactive workshops
ARCHILEX // ASSOCIATES OF CAPE COD // BIOMÉRIEUX // CHARLES RIVER
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
14:00
Coffee break - Visit of the exhibition
15:00
TBC
TBC
15:30
Risk Assessment & Data Integrity: ... what experiences
Luca BRANCA - OSIsoft
16:15
End of the event
16:45
Interactive workshops led by our partners (simultaneous workshops)
1 session: from 11h45 to 12h45
25 September
Pyros eXpress Software: the latest Endotoxin and Glucan Analysis Software
ASSOCIATES OF CAPE COD
Associates of Cape Cod, Inc. presents Pyros® eXpress software for the endotoxin and dehydration. The software allows the user to perform his test in a modo rapid and efficient manner.

-I modelli personalizzabili offrono opzioni di avvio rapido dei saggi con pochi passaggi mentrte the impostazioni di autorizzazione personalizzata consentono di controllare i test e ridurre gli errori. Utilizzabile sia con lettori di provette sia di piastre.
Classical or Rapid Microbiological Method? Focus on tomorrow's compendials
bioMérieux - Felix MONTERO
Esecuzione dei monitoraggi microbiologici: metodo tradizionale contro metodo "paperless"
ARCHILEX
Attraverso the simulazione dell'esecuzione di alcuni monitoraggi microbiologici verranno Mass confronto the metodologia classica e metodologia "paperless". He confronto si focalizzerà sui vantaggi in termini di risparmio i tempo, riduzione degli errori e generale efficactio materiale de la processo dal sistema paperless (tramite uso dei palmari e codici datamatrix), rispetto alla metodologia tradizionale che enta la registrazione manuale di tutte le attività svolte.
TBC
CHARLES RIVER
2 session: from 14h00 to 15h00
25 September
Disposable: the importance of Qualified Disposable for BET Assay
ASSOCIATES OF CAPE COD
Cosa è important sapere e cosa richiedere per il materiale usato nell'analisi BET
Rapid Micro Solution: what impact? What potential?
bioMérieux - Gilberto Dalmaso
Esecuzione dei monitoraggi microbiologici: metodo tradizionale contro metodo "paperless"
ARCHILEX
Attraverso the simulazione dell'esecuzione di alcuni monitoraggi microbiologici verranno Mass confronto the metodologia classica e metodologia "paperless". He confronto si focalizzerà sui vantaggi in termini di risparmio i tempo, riduzione degli errori e generale efficactio materiale de la processo dal sistema paperless (tramite uso dei palmari e codici datamatrix), rispetto alla metodologia tradizionale che enta la registrazione manuale di tutte le attività svolte.
TBC
CHARLES RIVER
3 session: from 11h15 to 12h15
26 September
Pyros eXpress Software: the latest Endotoxin and Glucan Analysis Software
ASSOCIATES OF CAPE COD
Associates of Cape Cod, Inc. presents Pyros® eXpress software for the endotoxin and dehydration. The software allows the user to perform his test in a modo rapid and efficient manner.

-I modelli personalizzabili offrono opzioni di avvio rapido dei saggi con pochi passaggi mentrte the impostazioni di autorizzazione personalizzata consentono di controllare i test e ridurre gli errori. Utilizzabile sia con lettori di provette sia di piastre.
Rapid micro solutions and regulatory changes for short shelflife products
bioMérieux - Charles Rio & Michael Wasmann
Esecuzione dei monitoraggi microbiologici: metodo tradizionale contro metodo "paperless"
ARCHILEX
Attraverso the simulazione dell'esecuzione di alcuni monitoraggi microbiologici verranno Mass confronto the metodologia classica e metodologia "paperless". He confronto si focalizzerà sui vantaggi in termini di risparmio i tempo, riduzione degli errori e generale efficactio materiale de la processo dal sistema paperless (tramite uso dei palmari e codici datamatrix), rispetto alla metodologia tradizionale che enta la registrazione manuale di tutte le attività svolte.
TBC
CHARLES RIVER
4 session: from 14h00 to 15h00
25 September
Lal Test and Endotoxin in difficult samples: biochemical interaction
ASSOCIATES OF CAPE COD
Come bypass the interference, da dove nascono e as individuarle.
Let us reflect together: difference between an alternative method and a compendial one
bioMérieux - Michael Wasmann
Esecuzione dei monitoraggi microbiologici: metodo tradizionale contro metodo "paperless"
ARCHILEX
Attraverso the simulazione dell'esecuzione di alcuni monitoraggi microbiologici verranno Mass confronto the metodologia classica e metodologia "paperless". He confronto si focalizzerà sui vantaggi in termini di risparmio i tempo, riduzione degli errori e generale efficactio materiale de la processo dal sistema paperless (tramite uso dei palmari e codici datamatrix), rispetto alla metodologia tradizionale che enta la registrazione manuale di tutte le attività svolte.
TBC
CHARLES RIVER
Workshops' end

You wish to reserve a table top, thank you to fill the following form

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Plan of the exhibition

SociétéN° StandSociétéN° Stand
 ASSOCIATES OF CAPE COD INTERNATIONAL INC. (partner)1 BIOMERIEUX (partner)6
 GSV Spa27
38
 ARCHILEX (partner)4 CHARLES RIVER (partner)9
 CONFARMA5

Services included with the Table Top stand

  • A dedicated exhibition space on which you can install your products and communication tools: umbrella stand, roll-up, display, product, ... A basic endowment including 180 x 45 cm table, 2 chairs and 1 electrical connection (2kw ) without protection circuit breaker.
  • Breaks and meals indicated in the program.
  • Unlimited Wifi.
  • A badge that allows you free access to the entire technical and scientific program.
  • The list of participants in the event.
  • Ability to register an additional person at the special rate "accompanying" (500 € HT).

You wish to reserve a table top, thank you to fill the following form

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Event Registration Form

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According to your requirements and your preferences, you can contact Natalina Semedo:

Phone: +33 (0)4 37 28 30 52
Fax: +33 (0)4 37 28 30 60
E-mail : nsemedo@a3pservices.com
Mail: A3P, 30 rue Pré-Gaudry - Lyon 69007
On site: 30 rue Pré-Gaudry, Lyon, from Monday to Friday

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