A3P

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logo congres2015 14 - 15 - 16 November 2017 - Biarritz
Conferences - Workshops - Exhibition

- Sterilization
- Single use
- Regulatory

Each year almost 650 professional from pharmaceutical and biotech industries meet in Biarritz to share their experiences et and explore the actual technical and scientific innovations.
3 themes were defined to guide the 2017 edition of the International Congress A3P: Sterilization, single use and regulatory.

Congress a3p v2 

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Section EXHIBITION Form REGISTRATION
 

Congress Program A3P 2017
Congress Center - Espace Bellevue, Biarritz (France)nce

  Tuesday, November 15th
08h00 Welcome at the Bellevue
08h45 Introduction
Gerard Ecotière- A3P Association President
09h00 Provisions for vaccine availability
Philippe JUVIN - Sanofi Pasteur
09h30

environmental risk analysis as a tool to meet the requirements of Chapters 3, 5 and 1 GMP Annex

Philippe DUHEM - Intertek France
10h00

Analytical Quality by Design: the integration required for Quality by Designtradsimul
Isabelle MOINEAU - Aktehom  & Véronique CHAMBON - Sanofi Pasteur

10h30 Break - Exhibition visit
11h30

Integrity Test Method for Helium: A case study on the development of a method for integrity testing of single-use systems using helium, integrated into a comprehensive strategy on the integrity of closed systems

Carole LANGLOIS - Sartorius
12h00

Analysis of the impact of the changeover to the single use in a filtration process for the production of Allergens

Pascal AOUDAY - ALK
12h30

extractable Impact Assessment related to the use of disposable equipment

Alain NONN- Lilly France
13h00 Lunch

14h30

connected medical device: what is the best technology to sterilize?
Chistophe DENEUX - Becton Dickinson 

15h00

Final sterilization for pharmaceutical applications: development of innovative customized solutionstradsimul
Annick GILLET & Bart CROONENBORGHS - Sterigenics

15h30

Is hydrogen peroxide vapor decontamination process considered a sterilization process?

Antoine AKAR - GSK Vaccines
16h00 Break - Exhibition visit
17h00 The Advantages and disadvantages of ready to use primary packaging material for aseptic filling - an overall comparisontradsimul
Daniel KEHL - Swissfillon AG
17h30 The use of single-use clinical insulator filling system
Franck PAVAN - Amatsi Group
18h00 Single use bags integrity testing: a validation 
François VANHERSECKE & Charlotte MASY - GSK Vaccines
18h30 Welcome cocktail

 

    Wednesday, November 16th
08h00
New

Interactive Breakfast - "With them ... the freedom to succeed! »At the Municipal Casino

Get up on your feet and start the day with spirit, energy and passion!
This is a new highlight, carried by the A3P Business Women, dedicated to the exchange and sharing of experience on a topical issue that crosses our professional lives.The tone will be that of benevolence; The theme will be the discovery of resolutely human projects and the whole will be treated with a bit of humor.


From this year onwards, a special session on the sidelines of the congress is organized to address cross-cutting issues that concern us all.For this first edition, we will look at Women in Business. You will hear portraits of women active in the Pharma, testimonials, examples of good practices, all animated by two quality animators: a journalist specialized and an expert in human capital management.

Join us to talk about it, to learn, to testify to your experience!

   
09h15   Reception of workshop participants at the Espace Bellevue
09h30 Workshops first part (see list below to choose your workshop to return on your registration form)
10h30 Break / Exhibition visit
11h00  Restart of workshops
12h30 cocktail buffet on show
14h00  Workshops second part
16h00   Break / Exhibition visit
16h30  Restart of workshops
18h00  Workshops' end
20h00   Gala dinner
   
    Workshops:
 N° 1

Serialization: an opportunity for CMOs and manufacturers of the drug?
Leaders : Hervé TASSERY
A3P Manager : Jean-Marc LIBERSA - Fareva & Nicolas ORANGE - Systech
abstract here

N° 2

Stability studies: understanding the most common problems and optimize protocols
Leaders : Pierre ANDRE
A3P Manager : Emmanuel BILLA - Cébiphar & Manuella MARTIN-JOUET - Ethypharm Laboratories
abstract here

 N° 3
English

Aseptic Process - How to answer to remarks Following inspections (eg FDA, ANSM, ANSES)
Leaders : Sophie AMADIO GB chip web 01
A3P Manager : Olivier CHANCEL- Merial & Walid EL AZAB - Steris
abstract here
 N° 4 Tools and tricks to take the time to stop for repairs
Leaders : Jonnathan TAFFORIN
A3P Manager : Nathalie ROBINEAU - Pasteur Institute Dakar & Damien POUPRY - Qualis Expertise

abstract here

N° 5 Pharmaceutical waters 4.0: the quality control for predictive maintenance
Leaders : Alain RACHON
A3P Manager : Laurent MEURISSE - Sanofi & Samah RINGA - Suez

abstract here

N° 6
Come challenger with us your knowledge of cleaning and disinfection and learn how you can optimize the performance of your cleaning processes
Leaders : Anne RIGOULOT
A3P Manager : Françoise DURAND - Laboratories Anios & Benoît RAMOND - Sanofi
abstract here
N° 7

Audits and inspections control laboratory
Leaders : Eric PETAT
A3P Manager : Philippe TIVOLLIER - TRB Chemedica & Philippe TAILLIEZ - ACM Pharma
abstract here

N° 8

Cleaning Validation: Application of Annex 15 European GMP manufacturer shaping a site of sterile products, non-sterile
Leaders : Isabelle SARFATI
A3P Manager : Ségolène BILLES - Fareva Amboise & Pierre DEVAUX - UPS Consultants
abstract here
N° 9
Appendix 15 / ASTM E2500: "Let's cross the bridge!"
Leaders : Patrick HIBON DE FROHEN
A3P Manager : Stéphane BERTRAND - Lilly & Maëlle DESREUMAUX - Assystem

abstract here

 N° 10 A day of immersion in water, environment, quality and quality control, regulatoryPicto debutant 01
Leaders : François MOREL
Moderator:Jérôme DONON - A3P
abstract here 
 N° 11
Data Integrity and production systems: how to prevent the inspection observations on this subject?
Leaders : Jean-Louis Jouve
A3P Manager : Hervé CLUZEAUD - Assystem & Thierry DUFRASNE - BaxterWorld Trade sprl 
abstract here
N° 12 Regulatory developments and medical devices: issues and impacts, how to prepare for and adapt to them
Leaders : Didier MEYER
A3P Manager : Axelle CRESSENVILLE - SGS & Kim ROUAHI - Biotechni

abstract here
N° 13
English
New Annex 1 (draft) impact on Equipment Design. Flexibility Regarding RABS gold ISOLATORS 
GB chip web 01
Leaders : Vincent GRIFFOUL
A3P Manager : Jean-François DULIERE - ISPE France / Technip & Frank LEHLE - Vetter

abstract here

 

  Thursday, November 17th
09h00 Welcome at the Bellevue
09h30

Sterility insurance, from 10-6 to 10-3, what security do we want?

Dominique WEILL - DoWeLi Sarl
10h00 Open the field less conventional techniques in sterilization and initial bioburden reduction
Alain EUZEN - Axys Network
10h30 Break - Exhibition visit
11h30

ICH Q3D (Basic Impurities) An example of implementation in a Contract Manufacturing Organization (CMO)

Delphine BOIVIN and Marina DAUBARD - Excelvision
12h00

Cost effective data integrity compliance program in a flexible cGMP environmenttradsimul

Jean-Sébastien DUFRASNE & Fabrizio PASQUA - Baxter World Trade sprl
12h30

The Revolution of Innovative Therapy Medicines (MTI): The Challenges of Pharmaceutical Production and Their Implications for Health Economics

Anne FIALAIRE-LEGENDRE - EFS
13h00 Lunch and conclusion of the A3P Congress

 

Contact : Mylène RAT - Such. 04 37 28 30 40 - Mgarlic.This e-mail address is protected against spambots. You need JavaScript enabled to view it.

 

 

 

 

 

Serialization: an opportunity for CMOs and manufacturers of the drug?


Moderator A3P : Hervé Tassery
facilitators:
Jean-Marc LIBERSA - Fareva & Nicolas ORANGE - Systech

This workshop will recall the requirements of serialization in Europe and the US, the impact on packaging lines and organization of production lines and more generally on the company.
The workshop will establish a project management group for the establishment of a line of serialization and next regulatory compliance to highlight the benefits brought about by serialization.
Participants will be asked to define: project groups, corporate strategy towards serialization, criterion of equipment selection, quality requirements, planning of implementation, allocation of resources ... and the expected benefits.

 

 Consult the full program of the Congress // View A3P Congress program

 

Stability studies: Understand the most common problems and optimize protocols


 

Moderator A3P : Pierre ANDRE
facilitators: Emmanuel BILLA - Cébiphar & Manuella MARTIN-JOUET - Ethypharm


After a reminder of the technical and regulatory bases linked to stability studies, the workshop will concentrate on the most frequently encountered concrete problems (and still not covered by the guidelines) for which the feedback from industry and specialized providers is paramount. The workshop will allow participants to have a global and precise vision of the implementation of stability studies on both the active ingredients and the finished products.

After a targeted review of various problems encountered (bulk products, transport, variations, sampling, impurities, etc.), the participants work in subgroups on specific cases:

- Establish a standard protocol
- Optimize protocol (notions bracketing / matrixing)
- Develop a stability protocol in use (in use stability)
- Interpreting the data and establish stability lapses and conservation recommendations

Restitution of cases studied by different groups concluded the workshop and led to the development of a synthesis of the various current approaches to stability studies.

This workshop is for anyone involved in the implementation or outsourcing stability studies for active ingredients and medications pre and post marketing authorization.

Consult the full program of the Congress // View A3P Congress program

 

Aseptic Process - How to answer to remarks Following inspections (eg FDA, ANSM, ANSES)

Moderator A3P : Sophie AMADIO
facilitators: Olivier CHANCEL - Boehringer Ingelheim & Walid EL AZAB - Steris

This workshop, in English, is Intended for everyone, novice or Experimented, and is regarded as a training, a way to discover, to Enhance one's "aseptic" cultural gold simply to test icts own arguments ... It will let participants design methodology is how to answer to whatever remarks they are and Then answer Altogether remarks Following an inspection on the aseptic field.
The workshop alternates sessions in a fast Rather way so as to favor the diversity and this year focus on the draft of the new annex 1, EU GMPs.

Consult the full program of the Congress // View A3P Congress program

 

Tools and tricks to take the time to stop for repairs

Moderator A3P : Jonnathan TAFFORIN
facilitators: Nathalie ROBINEAU - Pasteur Institute of Dakar & Damien POUPRY - Qualis Expertise

On a production site, a stop is always critical when it requires stopping workshops and impact revenue.
The workshop's goal is to work on the example of an aseptic production building to be renovated and in which equipment must be replaced and for which management does not accept a decision than 5 months.
Participants will work on project planning, scope of work, list of validation activities, trying to identify all the levers that will save time to meet 5 months.

Consult the full program of the Congress // View A3P Congress program

 

Pharmaceutical waters 4.0 release: the mastery of quality predictive maintenance

Moderator A3P : Alain RACHON
facilitators: Laurent MEURISSE - Sanofi & Samah RINGA - Suez

- Reminder of the regulations and recent developments on WFI.
- Reminder of the main techniques for production of water for pharmaceutical use (UPR & WFI) and maintenance solutions for physical, chemical and microbiological quality in distribution loops.
- Feedback: operational maintenance of production equipment and distribution of pharmaceutical water Site Vitry Sanofi R & D
- Case study: participants will be based on the schema of a production of purified water existing facility. The goal of the WS will be to upgrade the facility in order to improve its technical and economic performance.
- The focus will be on integrating SMART and implementing a predictive maintenance plan for quality control and cost optimization (CAPEX and OPEX).

Consult the full program of the Congress // View A3P Congress program

 

Come challenger with us your knowledge of cleaning and disinfection and learn how you can optimize the performance of your cleaning processes

Moderator A3P : Anne RIGOULOT
facilitators: Benoît RAMOND - Sanofi & Françoise DURAND - Anios

As a great team play on thè
Chemistry, good practices, microbiology ... you will confront your knowledge, your everyday practices, definitively sweep away your preconceived notions, leave with everything you have always wanted to know about the subject ... and, perhaps, will win The challenge?

Consult the full program of the Congress // View A3P Congress program

 

Audits and inspections control laboratory

Moderator A3P : Eric PETAT

facilitators: Philippe TIVOLLIER - TRB Chemedica & Philippe TAILLIEZ- ACM Pharma

The presenters present the current context in which audits and inspections are carried out in the internal or external control laboratories, in particular the objectives of these audits and the various reference systems used.
Workshop participants work in sub-groups on the conduct of audits of a QC laboratory.
The exercises integrate the technical and behavioral aspects of the auditor perspective and audited.
The groups will work on two areas:
- Auditors: evaluation in a limited time for compliance and risk related to the operation of a laboratory behaviors have as a specialist or generalist, themes ...
- Audited preparedness and responses, manage time to present the activities, demonstrate compliance with regulations.
Each group will restore its work to all participants in collaboration with the animators.

Consult the full program of the Congress // View A3P Congress program

 

Cleaning Validation: Application of Annex 15 European GMP manufacturing on a site forming sterile drugs and non-sterile

Moderator A3P : Isabelle SARFATI
facilitators: Ségolène BILLES - Fareva Amboise & Pierre DEVAUX - Teranga Group / UPS Consultant

This workshop proposes to show the practical application of the 10 chapter of Annex 15 of the European GMPs dedicated to the validation of cleaning at a sterile and non-sterile multiform shaping site. The day should make it possible to correctly interpret the 15 paragraphs of chapter 10 based on the practical guide published by the GIC A3P Validation of the Cleaning. This workshop will take stock of the latest regulatory trends including the calculation of acceptance criteria with the publication of a new guide at the beginning of the 2017 year calling into question the PDE approach for non-highly active products "Questions and answers (EMA / CHMP / CVMP / SWP / 169430 / 2012) "on the implementation of a risk-based approach to the prevention and control of cross-contamination in production

Consult the full program of the Congress // View A3P Congress program

 

Annex 15 / ASTM E2500: "Let's cross the bridge!"

Moderator A3P : Patrick HIBON DE FROHEN
facilitators:Stéphane BERTRAND - Lilly & Maëlle DESREUMAUX - Assystem

Billed as an alternative to traditional commissioning and qualification phases, the approach ASTM E2500 dream: saving time and money, refocusing and rationalization of quality on patient safety.
Encouraged by the prospects opened by Annex 15, more and more companies engage in this innovative way.
The objective of the workshop is to highlight the key points of effective implementation of this approach.
After a brief presentation of the text ASTM E2500, exchanges will be organized in gorupes work around concrete topics such as defining the need and design review, the partnership with suppliers, a pragmatic verification program ...

Consult the full program of the Congress // View A3P Congress program

 

A day of immersion in water, environment, quality and quality control, regulatory
Picto debutant 01

Moderator A3P : François MOREL
facilitators: Jérôme DONON A3P

New professional in the pharmaceutical industry, the objective of this workshop is to go back on fundamental and essential specificities for future managers.
This workshop will develop the essential topics. Exchanges with exhibitors on the stands illustrate the presentations made.
The topics will be: water and its various pharmaceutical qualities, air handling in clean rooms (laminar flow isolators, RABS), structures controlled environments (partitions, ceilings, SAS, ...), laboratories control (quality control, physical chemistry and microbiology) and the regulatory aspect (GMP, ICH, FDA, ...)
Industrial evoke their professional experience. Contacts will also be held with suppliers of fields.

Consult the full program of the Congress // View A3P Congress program

 

Data Integrity and production systems: how to prevent the inspection observations on this subject?

Moderator A3P : Jean-Louis Jouve
facilitators: Thierry DUFRASNE - Baxter & Hervé CLUZEAUD - Assystem

Data integrity, paper or electronic format, has become a major issue for the drug industry and health products. This reason is highlighted in many comments from US and European regulatory authorities under the generic term "Data Integrity".
The proposed workshop aims to:
- Clarify the definition of that term and expectations of regulatory authorities on the subject,
- Assess, through an industrial case study oriented production systems, the various risks associated with the "Data Integrity"
- To propose the technical and human resources to manage those risks.

Consult the full program of the Congress // View A3P Congress program

 

Regulatory developments and medical devices: issues and impacts, how to prepare for and adapt to them

Moderator A3P : Didier MEYER  
facilitators: Axelle CRESSENVILLE - SGS & Kim ROUAHI - Biotechni

The regulatory systems to which manufacturers of Medical Devices must subscribe, whether the product is disposable, implantable or even electronic, during their production and distribution are numerous and varied.
From 2017, these major repositories evolve for new directives involving the categorization of classes of Medical Devices on the one hand and the constraints that will now be associated with them as well.
From the development stages, the selection of raw materials, to the transport, the manufacturer will have to anticipate the rules to which he will henceforth be subjected.
The objective of this working group is to familiarize themselves with the regulatory developments under way and to understand and adapt them to each product or category of DM, in order to prepare the implementation for future inspections, placed on the market.

Consult the full program of the Congress // View A3P Congress program

 

 

 

New Annex 1 (draft) impact on Equipment Design. Flexibility Regarding RABS gold ISOLATORS

Moderator A3P : Vincent GRIFFOUL 
facilitators: Jean-François DULIERE - TechnipFMC & Frank LEHLE - Vetter

The objective of this workshop is to compare efficiency of RABS and ISOLATORS in relation to quality and business aspects. With the aid of a case study by a new innovative technology V-CRT® = Vetter clean room technology discussing when it is useful to implement a RABS or ISOLATOR filling line for aseptic applications. Particularly in relation to the new requirements of the Annex 1 through this workshop, the benefits of RABS systems. Attendee will be able to make the right decision for choosing the corresponding technology.

Consult the full program of the Congress // View A3P Congress program

 

 

 

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