A3P international Congress

Aseptic processes (Annex1, Media Fill, APS ...) / Visual inspection / CCIT / Environmental impact: the benefits of responsible pharmaceutical production

Location

Espace Bellevue, Biarritz (France)

Date

11, 12 & 13 October 2022

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Format

Conferences, workshops, exhibition

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Tuesday, October 11th

The A3P annual congress will be held this year on October 11, 12 and 13, 2022, in Biarritz, at the Bellevue.

This is the 33rd edition of this event which gathers every year the whole profession around the thematic of clean and sterile, whose stakes today are major for the pharmaceutical industry. In 2021, this event welcomed more than 750 participants.

This year, the 3-day program offers 16 conferences, with the participation of regulatory authorities, 17 interactive workshops, as well as an exhibition, which includes more than 110 exhibitors and is a major forum for exchange. These conferences are also an opportunity to share the progress of the work of the various working groups, the A3P GIC.

The conferences of the plenary session are organized around three themes:

. The visual inspection, CCIT, with interventions focusing on the technical challenges of this inspection, the qualification of a process, the HSA approach, the rejections and false rejections as well as the perspectives of digitalization.

. Aseptic processes, Annex1, MFT, APS... and the evolution of the regulatory environment around the “Contamination Control Strategy”, the opportunity to deal with topics such as PUPSIT, the improvement of sterility assurance and performance, human dynamics and collective intelligence in the service of “risk based approach”.

. Finally, the benefits of responsible production for sustainable health. This is an essential theme, especially in the current environmental context, with testimonials from major players in the pharmaceutical and biomanufacturing industries. Innovative sustainable solutions will be proposed.

17 workshops, of various themes, Contamination Control strategy, Monitoring and data integrity, cross-contamination, Lean tools … held over one day, will support this program of conferences, among which each participant will choose a theme that will be studied and debated in group during one day, within the workshop.

Together with our partners, we are waiting for you, even more numerous this year, to share with you these moments of technical and scientific discussions, always very professional and friendly exchanges that have helped build year after year the notoriety of the event.

Welcome of the participants
08:00
A word from the president
Jacques NAVELLOU
08:50
Presentation of the topic "Visual inspection - CCIT"
Cécile CHOPINET - SANOFI & Valérie RAUTUREAU - LILLY
Representatives of the A3P Visual Inspection GIC
09:00
Key findings related to ANSM inspections in 2020 and 2021 Annex 1: Review of the chapters dedicated to mirages.
Gabriel BERBARI - ANSM
09:15
Automated Visual inspection process validation : determination of standard approach and acceptance criteria for qualification and demonstration of equivalence
Cécile CHOPINET - SANOFI & Valérie RAUTUREAU - LILLY
Representatives of the A3P Visual Inspection GIC
09:45
Break - Visit of the exhibition
10:15
How to monitor and reduce false reject in automated visual inspection
Alban LANGLOIS - ASPEN PHARMA NOTRE DAME DE BONDEVILLE & Steven MAZOUIN - NOVONORDISK
Representatives of the A3P Visual Inspection GIC
11:15
How to evaluate batch quality based on rejects evaluation and how to prevent any risk linked to defects generation
Delphine AMOURET - ASPEN PHARMA NOTRE DAME DE BONDEVILLE & Sabrina DI VICO - LEO PHARMA
Representatives of the A3P Visual Inspection GIC
11:45
Interest of test sets before visual inpection of a batch
Florent MABBOUX - DELPHARM
12:15
Lunch
12:45
Digitalization Path for Visual Inspection
Romain VEILLON - GSK
14:15
HSA (Head Space Analysis), advantages and weaknesses of this leak testing method
Aurélien GENET - GSK
14:45
Ensuring Container Closure Integrity of a COVID-19 Vaccine Product Requiring Ultra-Cold Chain Storage and Distribution: A Holistic Science-Based Approach
Michael EDEY - PFIZER & Derek DUNCAN - LIGHTHOUSE
15:15
Break - Visit of the exhibition
15:45
Presentation of the topic "Aseptic Processes (Annex1, MFT, APS ...)"
Julian KAY - GSK & Julien TRIQUET - GSK VACCINES
16:45
Presentation of the new official version of Annex 1 of the EU GMP
Abdelaali SARAKHA - ANSM
17:00
Implementation of the PUPSIT at a CMO manufacturing site
Patrick COPPENS - ISOTEC'XEL & Stéphane COULEE - FAREVA
18:30
How to define and ensure worst case conditions during APS execution for freeze-dried products?
Dominique SIERAKOWSKI - DS ASEPTIC COMPLIANCE
19:00
Cocktail on the exhibition
19:30

Wednesday, October 12th

A3P Human Breakfast "Maladies rares et handicap invisible : regard croisé d'une initiative personnelle et d'une association de patients" at the Casino Municipal
07:30
The purpose of the workshops is to raise awareness or deepen theoretical or practical notions with the help of case studies that the participants must handle during a workshop in order to propose solutions in the form of conclusions, written with the help of the expert facilitators. The workshop group is composed of an A3P leader (or moderator) from the Board of Directors, two facilitators chosen for their recognized skills (1 manufacturer and 1 supplier) and attendees or exhibitors who have signed up by name. Over the course of a day, participants will exchange, work and debate on a technical or regulatory theme. Registration for the Congress allows you to participate in one of the 17 workshops that will be presented this year ( within the limits of available places)
09:30
Lunch
12:30
Second part of the workshop
End of the workshops around 18:00
14:00
Gala evening at the Casino Municipale
20:00

Thursday, October 13th

Welcome of the participants
08:30
Key current considerations, trends and challenges linked to Aseptic Process Simulations
Isabelle HOENEN - LILLY
09:00
CCS as a part of an initial registration file (BLA): a proactive and collaborative development
Antoine AKAR - HUMANIM LIFE SCIENCES & Jennifer HALLEY - UCB
09:30
Break - Visit of the exhibition
10:00
Presentation of the topic "Environmental impact: the benefits of responsible pharmaceutical production"
Samah RINGA - VEOLIA
10:45
Novo Nordisk : Development already committed to sustainable health
Xavier ROQUES - NOVONORDISK
11:00
Evolutive Vaccine Facility and carbon neutrality: which innovative sustainable solutions for a new agile manufacturing unit?
Estelle DOGER & Patrick POMMARÈS - SANOFI
11:20
Evolution of the environmental considerations of a Biomanufacturing site
Jerome PIONCHON & Jean-François MICHEL - MERCK BIODEVELOPMENT MARTILLAC
11:40
Question and answer
Xavier ROQUES - NOVONORDISK / Estelle DOGER & Patrick POMMARÈS - SANOFI / Jerome PIONCHON & Jean-François MICHEL - MERCK BIODEVELOPMENT MARTILLAC
12:00
Lunch and closing of the 2022 Congress
12:30

What is a workshop ?

Raise awareness or deepen theoretical or practical notions with the help of case studies that the participants must handle during a workshop in order to propose solutions in the form of conclusions, written with the help of the expert facilitators.
The workshop group is composed of an A3P leader (or moderator) from the Board of Directors, two facilitators chosen for their recognized skills (1 manufacturer and 1 supplier) and attendees or exhibitors who have signed up by name.
Over the course of a day, participants will exchange, work and debate on a technical or regulatory theme.
Registration for the Congress allows you to participate in one of the 17 workshops that will be presented this year ( within the limits of available places). List of workshops below.

CCS an essential tool for managing sterility assurance
Facilitators & Moderator : Members of the A3P Annex 1 GIC
  • Presentation of the A3P Guide and the tool to help structure a CCS
  • Focus on specific points of the document
  • Examples of situations to structure a CCS
  • CCS performance review (KPI)
Workshop 1 & 2
Prevention of contamination during aseptic or sterile production - The workshop is full
Facilitators : Patrizia MUSCAS - ELI LILLY ITALIA & Walid EL AZAB - STERIS
Modérateur : Sophie AMADIO - LILLY
This workshop in English is intended to provide discussions, sharing knowledge around the contamination control program to establish on complete parenteral manufacturing process (starting from drug substance thawing until primary packaging).
This workshop is intended for everyone, intermediate to experienced level, and should allow participants to analyze and discuss the critical aspects of the sterile process, to consider various situations of real cases failure that can occur.
Under realistic conditions, the workshop will lead the participants to consider a complete contamination control program, to discover real contamination situations, to search and define together effective CAPA.
Whenever possible, the workshop will illustrate the feedback with the expectation of the new Annex 1.
Workshop 3
No problem = no improvement. Lean tools, the LEAN mindset and concrete solutions to increase performance
Facilitators : Ronan LE FLOC'H - SANOFI & TBC
Moderator : Christophe MEUNIER - AKTEHOM
LEAN management or the pleasure to solve problems TOGETHER.
The LEAN management approach in terms of principles, state of mind, methodologies, tools, .... and the benefits obtained concretely will be presented, shared and also illustrated by your own situations.
No result without pleasure: this workshop will give you the pleasure to learn and understand TOGETHER why and how LEAN Management will help you to improve your expected performance.
Workshop 4
Monitoring and data integrity. The key to pharmaceutical water quality control
Facilitators : Aurélien PERIQUET - OCTAPHARMA & Samah RINGA - VEOLIA - Jean-Louis JOUVE - COETIC
Moderator : Hervé TASSERY - 5M PARTNER
After a brief reminder of the regulatory standards and best practices for the design and maintenance of pharmaceutical water production and distribution facilities, a large part of the workshop will be devoted to the study of a practical case of water loop by integrating issues of quality control and the relevance of monitoring, the use of data generated while associating the data integrity aspects.
Workshop 5
Tame my emotions and those of others to adopt effective stress management
Facilitators : Dominique BEN DHAOU - POINT NORTH & Nicolas QUOEX - SKILLSPOTTING
Moderator : Anne HAYS - A3P ASSOCIATION
Discover simple and practical tools to detect my emotions and those of those around me, then take action by using appropriate strategies in different situations.
Workshop 6
Comparison of two approaches for Visual Inspection Qualification and Equivalency Demonstration (manual, semi-automatic and automatic inspection) - The workshop is full
Facilitators: Membres du GIC A3P Inspection visuelle / Valérie RAUTUREAU - LILLY & Steven MAZOUIN - NOVONORDISK & Delphine AMOURET - ASPEN PHARMA NOTRE DAME DE BONDEVILLE & Jean-Michel TASSERIT - AVI
Moderator: Christophe BENOIT - ROMMELAG
Objective: to define a system allowing to maintain the qualified state of an automatic test pattern generator in routine

Summary: through the sharing of experiences and good practices, we will define the main causes of the loss of the qualified state of an automatic wiper, then the means of prevention and detection of these causes, and finally the method of verification of the system.

Target audience: current or future users of automatic testers
Workshop 7
Use of automatic inspection equipment on a routine basis and maintenance of its qualified status
Facilitators : Members of the A3P visual inspection GIC / Cécile CHOPINET - SANOFI & Sabrina DI VICO - LEO PHARMA & Alban LANGLOIS - ASPEN PHARMA NOTRE DAME DE BONDEVILLE
Moderator : Anne CASSART - LA SALLE BLANCHE
Objective: to define a system allowing to maintain the qualified state of an automatic test pattern generator in routine

Summary: through the sharing of experiences and good practices, we will define the main causes of the loss of the qualified state of an automatic wiper, then the means of prevention and detection of these causes, and finally the method of verification of the system.

Target audience: current or future users of automatic testers
Workshop 8
How to simply document aseptic filling activities so that the operator understands and follows them
Facilitators : Nathalie DELAHAYE - SANOFI & Alexis PRAYEZ - GSK VACCINES & Olivier DEPARDIEU - SINFONY
Moderator : Anne RIGOULOT - DELPHARM
The objective of the workshop is to lead participants to design a simplified Doc&Training architecture centered on Michel the operator, making it possible to reduce by 80% the documentation at the workstation and 50% the number of training sessions to be followed by Michel, without complex IT tools.
The workshop is co-hosted by Olivier DEPARDIEU from Sinfony, Nathalie Delahaye (from Sanofi Le trait) and Alexis Prayez (from GSK Saint Amand).
Participants will alternate between theoretical explanations given by Olivier, and practical exercises supported by GSK and Sanofi.
Participants will be guided by fill-in-the-blank models to be filled in with their own experience. The models will be built on the basis of the content used by GSK and Sanofi. They will then be able to quickly adapt the contents made by the two facilitating labs to their context.
At the end of this workshop, participants leave with a simplified Doc&Training architecture for aseptic filling activities. They will have built:
-The activity flowchart that shows the chronological sequence of activities
-The RACI responsibility table showing the interactions between operators assigned to different positions
-The list of video tutorials that Michel will have to produce to learn the right gesture.
-Each tutorial contains the EHS instructions, the quality instructions, the performance instructions, showing the participants that they can remove most of the cross-cutting SOPs.
- The ideal grouping of these tutorials into work instructions
The training course of Michel, a newcomer, on his aseptic filling station.
Ideas for training content to be integrated into the course to maximize Michel's understanding of his filling station (video learning kit, 360° visit, virtual reality, etc.).
They will have discovered some good practices to build prod tutorials, including aseptic.
They will be able to compare their Doc&Training architecture made in training with those set up by GSK and Sanofi.
Workshop 9
Implementation of a barrier technology on an existing process: options studied, challenges on the chosen solution
Facilitators : Nathalie ROBINEAU - INSTITUT PASTEUR DE DAKAR & Yoann VANEL - AVN
Moderator : Eric PETAT - ACM PHARMA
The draft of the new GMP Annex 1 increases the level of regulatory requirements in the manufacture of sterile medicinal products, in particular for aseptic processes. Thus, it should be interpreted that the implementation of physical barriers between the operator and the product is no longer a recommendation but a requirement. In the context of vaccine production in the current IPD unit, some transfers between equipment were previously carried out under a class A laminar flow cart.)
In 2020, the occasion of a revamping of the premises led IPD to think about the implementation of these transfers by other solutions than the laminar blowing carts in order to protect the product throughout the process by barrier systems.
The objective of the workshop is to reflect on the different possible options, to select one per group and to define the different steps with advantages/disadvantages until the implementation and qualification of the validated transfer solution.
Workshop 10
Development of an Integrated Container Closure Integrity Control Strategy
Animateurs : Henri HEBTING - LILLY & Matthias KAHL & Matthias HIDDEMANN - WILCO
Modérateur : Alain RACHON - MERCK
Participants will learn from the speakers how to develop a holistic CCI control strategy and how to select appropriate testing methods at the different stages of a product life cycle. Within focus groups, participants will develop a CCI risk assessment for a new product, at different stages of the life cycle. They will be asked to identify potential risks and propose remediations via appropriate preventions and controls. There will be also hands-on experience with a show case CCI method.
Workshop 11
How to define the criticality of a deviation and the depth of investigation
Facilitators : Arnaud HUC - ACADÉMIE DE LA QUALITÉ EFFICACE & Laura VIALLIS - EUROAPI
Moderator: Pierre ANDRE - LEO PHARMA
On production sites, one of the main challenges in terms of quality is the definition of the criticality of deviations. This important decision is the basis for important choices, how far to investigate the deviation, which deviations are communicated to customers and obviously which deviations are most likely to come out in inspection. And the worst part is that if your criticality definition system is not well defined, you may have similar deviations identified with a different criticality, which could be the source of an inspection remark.
During this workshop,
-We propose to quickly review what the regulations say about deviations.
-We will then lead a reflection on what is really involved in the classification of the criticality of deviations.
-Then we will lead a reflection in sub-group to identify the most relevant criteria to identify the criticality of your deviations.
-At the end of the workshop, we will apply these criteria to a few examples to see the results of this decision-making tool
Workshop 12
Implementation of a project for a new production unit with single use technology - The workshop is full
Facilitators : Bénédicte BONFILS – LILLY & Alain NONN – HUMANIM
Moderator : Jean-Louis BELMON - VIRBAC
First part: interactive theoretical presentations of the following topics by the facilitators: - Regulations
- Risk analysis
- Single use equipment (including supplier consultation and partnership)
- Process industrialization
- Project planning
Exchanges with the participants on these different themes then presentation by the facilitators to fix the main principles.
Part two: exercise in sub-groups
- Description of the single use manufacturing process of a liquid injectable drug in vials (animators)
- Subgroup exercise
1. Analysis of the risks induced by single use technology
2. For selected risks, definition of the studies to be carried out
3. Definition of process development protocols
4. Proposed process control strategy
The subgroups will report back and exchange ideas at the end of each step (1 to 4) of the exercise in order to set the pace for the day and to ensure that each subgroup is making progress.
Workshop 13
Cross-contamination control in barrier technologies
Facilitators : Antoine TOUSSAINT - GSK & Laurent MERLI - THERAXEL
Moderator : Xavier SCHLIENGER - LFB
Beyond the control of particulate and microbiological contaminants, GMP requires the implementation of a cross-contamination control strategy (chemical or biological risks). How to apply it to our barrier technologies (BSC, RABS, isolator)? In the context where the draft of annex 1 requires to determine and validate "hold-times" for each step of the manufacturing process including intermediate phases (inter-campaign, inter-batch), how to implement cleaning and disinfection during a production campaign to meet regulatory expectations?
Workshop 14
Impact of the evolution of Annex 1 on the validation of bio-cleaning
Facilitators : Marie-Bénédicte TESSIER - VETOQUINOL & Céline MARGERIE - COPHACLEAN
Moderator : Didier MEYER - DMCOMPLIANCE
The biocleaning of the premises is an essential element in the Control Contamination Strategy. It requires several steps to ensure the effectiveness of the detergents/disinfectants used, but also to demonstrate the performance and control of the chosen biocleaning processes. After a quick regulatory review and definitions of biocleaning and disinfection, the different steps of biocleaning validation will be detailed (in vitro then in situ). Then, in sub-groups, based on concrete cases from the pharmaceutical industry, we will reflect on the different strategies to adopt for the realization of the in situ validation and the definition of the different criteria/specifications. We will end the workshop by reflecting on the monitoring strategy of the biocleaning of the premises.
Workshop 15
Verification of Pharmacopoeia methods
Facilitators : Gerald DE FONTENAY - CEBIPHAR & Elise GALLAIS - LFB
Moderator : Christophe EMONARD - BIOMERIEUX
Version 11.0 of the European Pharmacopoeia, published in July 2022, includes a new chapter 5.26, which will be implemented as of January 2023. This chapter describes the expectations in terms of verification of the methods described in the PhEur monographs, before a first implementation.
  • What does this chapter say?
  • Is this new?
  • Does this apply to all methods?
  • How will this impact my work in the lab?
  • How can I anticipate this change?
  • Are my internal procedures in line with these expectations?
  • What similarities/differences with the USP <1226>?
This workshop is an opportunity to share practices between participants and to define, if possible, a consensual way to manage pharmacopoeial method implementation
Workshop 16
Workshop for students. A day of immersion in the pharmaceutical industry: EPPI water, environment and ZAC, control and quality, regulations
Facilitators : François MOREL – A3P ASSOCIATION & Dominique SIERAKOWSKI - DS ASEPTIC COMPLIANCE & Mats MICKOS – PHARMTEC & Gwenaëlle CLECH – 5M PARTNER & Bénédicte GAS - CHARLES RIVER
Moderator : Jonnathan TAFFORIN – A3P ASSOCIATION
Description coming soon
Workshop 17

Exhibition 2022 complete

Sociétén°stand
ABC TRANSFERO14
AEROMETRIKO6
AKTEHOMF11
ALBHADESR21
ALFA LAVALR15
AMSONIC – HAMOR23
ASSOCIATES OF CAPE CODO36/O37
ATEC PHARMATECHNIKB1
ATRYONO13
AVNK5
BACCINEXO41
BATIMPRO CHARRIERR12
BAUSCH + STRÖBELR7
BECKMAN COULTERO22
BIOMERIEUXO43/O44
BOURSIER SOGREGO21
BIOQUELL (ECOLAB)O32/O33
BTFB2
BWTO42
CARBOGEN AMCISO38
CARSO LSEHLR9
CCITK6
CHARGEPOINT TECHNOLOGYF8
CHARLES RIVER LABORATORYR26
CHRISTEYNSF4
CONFARMA FRANCEF2
CONFORMATO2
CONTEC INCO9
COPHACLEANO48
DEVEAR22
ELIS CLEANROOMO24/O26
ELLABK4
ENDRESS+HAUSERR30
EREA PHARMAK17
EUROFINS BPT FRANCEF15/F15BIS
FPS PHARMAK16
GASPOROXK12
GETINGE FRANCEF6
GIVE & TECHO3/O4/O5
GOMETROLOGIEK14
GROUPE ICAREO11
GROUPE JBTKO3
HAMILTON BONADUZR28
ILC DOVERF10
IMA FRANCEF16
INITIAL CLEANROOMSO30
INTERSCIENCEF12
INTERTEK FRANCEO27
IWT PHARMAO42BIS
JBTKO3
JCE BIOTECHNOLOGYO52
KAYE – AMPHENNOLKO1
KÖRBER PHARMAO19
LABORATOIRE HUCKERT’SF7
LABORATOIRES ANIOSO18
LAPORTE EUROR27
LIVES INTERNATIONALK8
LONZAO45
LSB LA SALLE BLANCHER32
LUCISBIOO12
MERCKF13/F14
MESALABSR4
METTLER TOLEDOO29
NEOVIX BIOSCIENCESK2
NORDTESTK15
NOVATEK INTERNATIONALR20
OPTIMA PHARMAO46
OXY’PHARM – SANIVAPR25
PALL CORPORATIONO16/O34
PAMAS FRANCEF1
PARKER HANNIFINR5
PFEIFFER VACUUMO7
PHARMAPLANR24
PHARMASEPO47
PHARMTECO17
PMT FRANCEO23
PQE GROUPKO5
PROSYS GROUPR10BIS
RAPID MICRO BIOSYSTEMSO28
RAUMEDICK7
REALCOR14
ROMACOKO2
ROMMELAGR8
RT2IK1
SALAMANDERUF9
SARTORIUSO1
SCHOTT PHARMAO20
SCHREINER MEDIPHARMO49
SCHÜLKEO51
SGS HEALTH SCIENCEO50
SHERPAPHARMAK3
SIDJIO8
SKANF3
SOFASTR29
SOLIDFOG TECHNOLOGIESR31
STÄUBLIO40
STERIFLOWK9
STERILINEK10
STERISR16/R17/R18/R19
SUEZ – SIEVERS INSTRUMENTSK11
SWANR3
SYMBIOSE ENVIRONNEMENTF17/F18
SYNEXINO25/R1
SYNTEGON TECHNOLOGYO39
SYSTEM-C BIOPROCESSKO4
TECHNIP ENERGIES FRANCER6
TECHNOCHIMR13
TEGR10
TELSTARO31
TERANGA GROUPEO15/O35
THERAXELR11
VALTRIAF5
VENAIRO10
VEOLIA WATER TECHNOLOGIESR2
WARANET SOLUTIONSK13
WILCOR7.

Exhibition 2022 complete

Exhibition 2023

 

Important note: All exhibitors present in 2022 will be given priority for their booth reservation in 2023.
If you wish to be on our waiting list and receive the availability of stands*, please complete the form below:
Waiting list form A3P 2023 Congress

*Available locations will be announced in the second quarter of 2023

Infos & Tarifs*

Tarifs hors Adhésion A3P obligatoire : https://www.a3p.org/adhesion/

Registration form

A3P International Congress

Once you have completed this form, you will receive a copy by email

Registration fee : 1300€ EXCL. TAX (VAT 20%) + A3P membership is mandatory (additional fees apply if you are not yet a member).
To find out if you are a member, please contact us.
To know the rates, please refer to the Membership section of the site.

Contact

Depending on your requirements and preferences, you can contact Ludivine BAYLE (exhibition) or Natalina SEMEDO (program & registration):

Phone : +33 (0)4 37 28 30 40
Email : lbayle@a3pservices.comnsemedo@a3pservices.com

Accessibility

Air France Booking

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Event: Congrès A3P Biarritz 2022

ID Code: 37743AF
Travel Valid Period: 24/09/2022 to 06/11/2022
Event location: BIARRITZ-BAYONNE

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