Congress A3P Tunisia
Conferences - exhibition - workshops

LOCATION

Hotel the Russelior - Yasmine Hammamet - Tunis

DATE

April & 25 26 2019

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FORMAT

Conferences, Workshops, Exhibition

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Since 2004, A3P Tunisia (Association for clean and sterile products) has for major objective to be a real place of exchange and meeting between the manufacturers of the pharmacy sector and their suppliers in Tunisia.

The office A3P Tunisia brings together a college of manufacturers and a college of suppliers from Tunisian industries.

Its annual Congress, thanks to this peculiarity becomes in fact the inevitable event of Clean and Sterile.

For two days, it brings together all the professionals of the sector.

Its conferences, all related to current topics and its unique workshop format allow to discuss regulatory and technical issues of production and control in direct relationship with the professional daily. An exhibition allows each of the suppliers and service providers to be the technological showcase of reference in its field.

The conviviality of the association and the organization of the sessions bring the comfort and the serenity necessary for fruitful exchanges.

Official language of conferences: Français

Thursday April 25 2019

Welcome of participants
08:30
Introductory speech
Noureddine Ghariani
President of A3P Tunisia
9:00
The human being, a competitive asset and a lever of success in a changing world
Dominique Ben Dhaou
Point North
9:30
Clinical Studies / Bioequivalence Studies
Meryem Khrouf
DPM
10:00
Break and exhibition visit
10:30
Process validation integrated into the product life cycle: a rational and scientific approach to improve process knowledge, control and performance and to obtain reliable and quality products.
Anne Rigoulot
Sanofi
11:00
Iso 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
Amel Chaherli
11:30
Lunch break
12:30
Lyophilization of injectable forms. Contamination control
Dominique Sierakowski
DS Aseptic compliance
14:30
No sterilization without process validation
Dominique Weill
Doweli
15:00
Break and exhibition visit
15:30
Quality By Design: constraints or opportunities?
Alain Bernard
R Pharm
16:00
Cocktail offered by Sterigene
16:30

Friday April 26 2019

Welcome of participants
09:00
First part of the workshops
9:30
Break and exhibition visit
10:30
Restart of workshops
11:00
Lunch break
13:00
Second part of the workshops
14:00
Closing of the congress and cocktail
16:00
Application of the validation approach of an integrated process around a concrete case with the 3 major steps
Anne Rigoulot
Step 1: definition of the industrial process. Implementation of the criticality analysis approach for the definition of critical quality attributes and critical parameters including the identification of elements to be put in the regulatory file  2 step: process validation: Definition of a protocol reproducibility and comparability study including the analysis of the results in case of anomaly and the statistical analyzes of comparability.  Step 3: continuous verification: Definition of the verification protocol of the previously validated process including statistical analysis and associated tools (control charts, capability indices, MSP).
1 workshop
A day of immersion in water, the environment, control and quality, the regulations
François Morel
The aim is to come back to the fundamental peculiarities of the pharmaceutical industry, which is essential for future managers or executives. The subjects treated will be water and its various pharmaceutical qualities, air treatment in clean room (laminar flow, insulators, RABS) structures controlled environments (partitions, ceilings, airlock, ..), control laboratories ( quality control, physical chemistry and microbiology) and the regulatory aspect (GMP, ICH, FDA, ...)
2 workshop
Quality by design
Alain Bernard
"The QbD has been proposed primarily by the FDA many years ago.There are many misconceptions, fears, rejections or adoptions in different parts of the pharmaceutical industry The workshop aims to" demystify "the concepts, explain how the QbD works and can be implemented without much trouble, we will explain how this implementation is done in order to develop the products and processes on a more scientific, integrated, proactive basis and with a knowledge of calculated risks. We will generate a few QbD steps, demonstrating how technical development can strengthen our understanding of products and manufacturing processes, and participants will realize how this development can ensure the highest quality of future products, without relying solely on the final quality control The cases to be studied will give a clear idea of the added value brought by the QbD "
3 workshop
Validation of sterilization processes
Dominique Weill
Description 3
4 workshop
Lyophilization: Loading and unloading of lyohilizers
Dominique Sierakowski
Loading and unloading freeze dryers: automatic, semi-automatic, manual: how to evaluate the different possibilities; what criteria to consider; how to make choices that meet the quality (contamination control), productivity and financial requirements.
5 workshop
Biological residues, chemical traces: how to make good cleaning practices coincide with the detection thresholds?
Michel Etienne
New chemical entities and products derived from biotechnology processes are most often complex processes, coupled with significant toxicological risks. However, common or similar strategies can be developed on templates that fit into the Good Cleaning Practices. This workshop, based on practical examples, will demonstrate how far cleaning validation can go before considering the use of single-use components.
6 workshop

You wish to reserve a stand, please consult our exhibitor file

Download the PDF file

Plan of the exhibition

CompanyNo. StandCompanyNo. Stand
EUROMAGHREB1ASSOCIATES OF CAPE COD11
ANACHROM2SOMAPP ++12
BIOQUELL3CAREP13
SOPHIDIS4INITIAL CLEAN ROOM14
HPM PACK GIE5CLEAN HEALTH SERVICES15
Climed6 STE MAGHREB16
HPM PACK GIE7
ROMMELAG8
REPCO9
LM CONSULTING10

Services included with the stand

  • A dedicated exhibition space where you can install your products and communication tools: umbrella stand, roll-up, display ... delimited by a structure with bottom walls and returns.
  • A basic endowment including 180 x 80 cm table, 2 chairs and 1 electrical connection (16A, 300 kw) without protective breaker
  • Breaks and meals indicated in the program
  • Unlimited WiFi
  • A badge that allows you free access to the entire technical and scientific program
  • List of participants in the event
  • Ability to register an additional person at the special rate "accompanying" (590 € HT)

Event Registration Form

At the end of this form you will receive a copy by email of the information provided.

Registration







participant information
Billing Information
A3P Communications / Receive our communications
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Contact

Depending on your requirements and your preferences, you can contact:

A3P Tunisia:

Phone: 00 216 93 190 757
E-mail : a3ptunisie@gmail.com
Mail: A3P Tunisia, BP.38, ZI Kalâa Kébira - 4060 - Tunisia

A3P Services:

Phone: 0033 4 37 28 30 40
E-mail : shamriche@a3pservices.com
Mail: A3P Tunisia, 30 rue Pré-Gaudry - Lyon 69007

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Hotel reservation

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