A3P International Congress

Annex 1 GMP EU / Single Use Systems / Remote Audit

Place

Espace Bellevue, Biarritz

Date

23, 24 and 25 November 2021

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Format

Conferences, workshops, exhibition

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What a joy to see you again for the unmissable meeting of the profession which will take place on 23, 24 and 25 November 2021 in Biarritz.

This event will be structured, as it has been since its creation, around fifteen conferences and a round table, an exhibition of more than 90 suppliers and 16 workshops to move from theory to practice. For this 32nd edition, it will be centred around three themes that are current in the clean and sterile sector.

First of all, the new Annex 1 of the EU GMP, whose publication of the final version will lead to profound changes in practices. A3P has not waited for this publication to start organising the reflection and sharing on its implementation. The A3P GIC “Annex 1”, which has been a driving force on this annex since 2015, will take advantage of this forum to provide initial feedback on the key points of this text, such as the implementation of the CCS. Throughout these three days, exchanges will take place, including with the supervisory authorities, within the framework of a round table open to all, conferences and workshops.

A3P will also address new technologies, for example through the increasingly important use of Single Use Systems. How to manage the deployment, use and maintenance (Life Cycle Management) of Single Use solutions? You will be able to exchange or share information with manufacturers and suppliers on key SUS issues such as validation, environmental impact, integrity testing or extractables and releasables which will be covered in conferences or workshops led by specialists in the field with whom you will be able to interact.

Finally, over the last two years, the health context has changed certain practices, such as auditing. We had to reinvent this well-tried approach and continue to audit without being able to travel. The remote audit has almost become the norm, but what are the advantages and disadvantages of this practice for the auditor? For the auditee? and what do the authorities think? Is this approach destined to become the new normal? The A3P GIC “Remote Audit” will present the guide developed on this subject and auditors and auditees will come and talk about their experiences of remote auditing.

Conviviality, good humour and exchanges which we have missed so much and which are the DNA of A3P, will be the rule for these 3 days where we hope to meet you again to catch up on lost time and work together on the future of our beautiful association.

Official language of the conferences: French
Simultaneous translation of conferences: French <-> English

Tuesday 23 November

Welcome of the participants
08:00
A word from the President
Jacques NAVELLOU
08:50
Presentation of the topic "Remote Audit
Anne HAYS - CARSO & Pierre ANDRE - LEO PHARMACEUTICAL PRODUCTS
09:00
Experience from a Remote Inspection
Siobhan McBRIDE - GUERBET
09:15
How to conduct and prepare for remote audits?
Assia BAGHLI - BIOGARAN & Marie-Noel MAUMUS - GIANELLI MAUMUS PARTNERS consultants (GMPc) / CERTIPHARM
09:45
Break - Visit of the exhibition
10:15
Presentation of the topic "Single Use Systems"
Philippe WAGHEMACKER - SANOFI & Camille DESROUSSEAUX - THERMO FISHER SCIENTIFIC
11:15
Securing the SUT supply chain: what lessons can be learned from the pandemic crisis? how did the pre-Covid operating methods show their limits? proposal of strategies to be implemented to ensure the robustness of supply
Marie-Agnès BOL - LFB & Katell MIGNOT - SARTORIUS STEDIM FMT
GIC A3P Single Use Representatives
11:30
Integrity on Single Use Systems Used in Sterile Applications – What are the Annex 1 Requirements and the Good Practices Based on a Case Study in Vaccines.
Charlotte MASY - GSK VACCINES
GIC A3P Single Use Representative
12:00
Lunch
12:30
Carbon footprint compared between a Stainless Steel and Single Use process for a 500L bag
Vincent BECHTEL - NEXTPHARMA & Cyril KEREBEL - CCONSEIL
GIC A3P Single Use Representatives
14:30
BIO-S springboard to Factory 4.0 for Servier
Frédéric BARNAY-TOUTAIN & Catherine SACHOT - SERVIER
15:00
URS single use feedback (assembly / RTS or RTU article) in an up stream building project
Alain BRIERRE - SANOFI
15:30
Break - Visit of the exhibition
16:00
Presentation of the topic "Annex 1 GMP EU"
Julian KAY - GSK
17:00
CCS implementation: feedback from the GSK Dresden site
Nicolas BOURGEOIS - GSK & TBC - GSK DRESDEN
17:15
CCS implementation: feedback from the OxfordBioMedica site
James DRINKWATER - PHSS & TBC - OXFORDBIOMEDICA
17:45
Cocktail on the exhibition
18:15

Wednesday 24 November

A3P Human Breakfast at the Casino Municipal
Inclusion and solidarity : "Le XXI" & "Pharmadis"
The specificities of the professional inclusion of people with disabilities, in catering and pharma. The genesis of the creation projects of these different companies, their challenges and anecdotes.
07:30
Start of the workshops at the Espace Bellevue
The purpose of the workshops is to raise awareness or to deepen theoretical or practical notions with the help of case studies that the participants must work on during a workshop in order to propose solutions in the form of conclusions, drawn up with the help of the expert facilitators. The workshop group is made up of an A3P administrator (or moderator) from the Board of Directors, two facilitators chosen for their recognised skills (1 manufacturer and 1 supplier) and congress participants or exhibitors who have registered by name. During the day, the participants will exchange, work and debate on a technical or regulatory theme. Registering for the Congress allows you to participate in one of the 16 workshops that will be presented this year ( according to the number of places available)
09:30
Lunch
12:30
Resumption of the second part of the workshop
And of Workshops around 18:00
14h00
Gala Dinner
20:00

Thursday 25 November

Welcome of the participants
08:30
Audit of a sterile site according to the 2020 Draft of Annex 1: Sensitive topics and feedback
Pierre DEVAUX - THERAXEL
09:00
How the CCS served as a guiding principle for the largest industrial pharmaceutical investment in France _ The LFB site in Arras
Stéphane CHABANON - LFB
09:30
TBC
TBC
10:00
Break - Visit of the exhibition
10:30
Discussion panel Annex 1 GMP EU (Discussions, exchange of views and Q&A)
Abdelaali SARAKHA - ANSM & Members of GIc A3P Annex1
Moderator : Julian KAY - GSK
11:15
Lunch and closing of the 2021 Congress
12:45

What is a workshop?

Raising awareness or deepening theoretical or practical notions with the help of case studies that participants must work on during a workshop in order to propose solutions in the form of conclusions, drafted with the help of expert facilitators.
The workshop group is made up of an A3P administrator (or moderator) from the Board of Directors, two facilitators chosen for their recognised skills (1 manufacturer and 1 supplier) and congress participants or exhibitors who have registered by name.
During the day, the participants will exchange, work and debate on a technical or regulatory theme.
Registration for the Congress allows you to participate in one of the 16 workshops that will be presented this year (subject to availability). List of workshops below.

How to adapt integrity control and PUPSIT strategies to the use of Single Use Systems
Facilitators: Members of the A3P Single use GIC
Moderator : Jean-Louis BELMON - VIRBAC
After an introduction recalling the presentation of the problematic and the presentation of the risk assessment approach, the workshop will alternate presentations by experts (technical or methodological) with concrete practical exercises to illustrate possible strategies for demonstrating integrity. The situations worked on will make it possible to make the link with the new version of Annex 1 of the EU GMP and will be associated with :
-The implementation of a filtration (PUPSIT).
-The use of bags connected to fixtures.
-The use of SUS in non-sterile situations but requiring integrity for safety aspects (containment).
-Use of SUS not having sterile status but used in an aseptic process (without subsequent sterilising filtration)
Workshop 1
Presentation of the GIC Single Use tools / selection of connectors and SU pockets / Validation + Regulatory Guides
Facilitators : Membres of the A3P Single use GIC
Moderator : Alain RACHON - MERCK
- Introduction
-Feedback (Project, Project Drivers, Choice of Single Use, Consideration for the design, Challenges)
-How to introduce SUS, presentation of the tools developed by the GIC (Tools and Guides)
-Exercises in sub-groups
-Restitution & conclusion
Workshop 2
Technology transfer from a traditional stainless steel process to a single use process
Facilitators : Catherine MICHAELI - LILLY & Alain NONN - ALPHA PHARMA CONSULTING
Moderator : Christophe BENOIT - ROMMELAG
Theme: In the first part, the facilitators will introduce the themes that will be implemented by the participants, which are:
-Regulation
-Process validation: the three stages of validation according to the life cycle of medicines
-Technology transfer
-Risk analysis
-Single use equipments
Participants will then work in sub-groups to propose the studies to be carried out in the context of technology transfer on the basis of a risk analysis, as well as a validation strategy for the new process.
Workshop 3
Remote Audits and Inspections
Facilitators : Jean-François DULIERE - ISPE & Margot GILBERT - LABORATOIRE AGUETTANT & Cindy GOBAUT - BRACCO SUISSE SA & Hélène BUZAT - UPSA SAS
Moderator : Pierre Andre - LEO PHARMACEUTICAL PRODUCTS
The pandemic has brought remote audits into the spotlight. In this workshop we will look at the regulatory requirements for remote assessment. The objective of the workshop will be to see the expectations of the health authorities and to study the ways to prepare for these remote assessments but also how to conduct and prepare for supplier audits on both the auditor and the auditee side.
Workshop 4
Contamination control strategy
Facilitators : James DRINKWATER - PHSS & Nicolas BOURGEOIS - GSK & Di MORRIS - ASTRAZENECA PHARMACEUTICALS & Sandrine FAVRE - OCTAPHARMA
Moderator : Julien TRIQUET - GSK
Description coming soon
Workshop 5
Management of Out of Specification and Out of Trend (OOS - OOT) results in the control laboratory: Requirements and Processing Strategies
Facilitators : Mathieu BOIRET - DELPHARM & Guillaume PINON - ACM PHARMA
Moderator : Eric PETAT - ACM PHARMA
The first part of the workshop will be devoted to the description of the current regulatory requirements on the definition of an out-of-specification, out-of-limit and out-of-trend result and their commentary. After defining the different types of out-of-specification or out-of-limit results expected according to the type of test and the context, a review of the available literature on the subject will be carried out.

The participants will then work in groups on concrete cases of analytical or microbiological OOS/OOT results.

The work of each group will be presented and all the materials will be given on a USB key at the end of the workshop.
Workshop 6
Design Management of an Isolator to optimise its Decontamination Process (Cleaning then Disinfection)
Facilitators : Cécile AUBARET - UNITHER COUTANCES & Patrick COPPENS - ISOTEC'XEL
Moderator : Jonnathan TAFFORIN - A3P ASSOCIATION
The Isolator Decontamination Process is, according to the latest draft of GMP Annex 1, an essential process to ensure the control of contamination in an aseptic isolator distribution line. As such, it is fundamental to take this subject into consideration very early on, from the first stages of its conception and design. The drafting of the User Requirement Standard must be very precise, enabling the line to be mocked up. Other subjects are concerned (Environmental Monitoring Strategy, Positioning of Gloves/Sleeves, etc.). This workshop will be based on a practical case study carried out with Unither Coutances for the decontamination aspect and will also allow participants to benefit from the numerous feedbacks from other customers of Theraxel and Isotec'xel on the subject while taking into account the regulatory context. Beyond the decontamination of an isolator, this workshop will talk about Barrier Technologies and will also be able to answer your questions about RABS and their differences with isolators.
Workshop 7
Prevention of contamination during aseptic or sterile production: practical cases AND practical demonstrations
Facilitators : Olivier CHANCEL - MERIAL & Walid EL AZAB - STERIS
Moderator : Sophie AMADIO - LILLY
The purpose of this workshop in English is to offer discussions, practical demonstrations with real equipment as well as potential impacts on the aseptic process simulation activities. This workshop will include different real cases that actually caused contamination, in connection with sterile production. Depending of the current sanitary context, we aim at offering some practical outreaches with suppliers on topics related to the concept of Contamination Control Strategy (focus EU GMP Annex 1).

This workshop is intended for everyone, intermediate to experienced level, and must allow participants to exchange and discover various situations that can take place everywhere, even « at home »... In realistic conditions, the workshop leads participants to discover a contamination situation which has occurred elsewhere, to seek together not the direct causes but the root cause of the deviation in order of course to prevent them to occur again. To this end, suggestions arising from the root causes will be proposed. The workshop will not fail whenever it is possible to illustrate feedback with the expectations of the coming annex 1
Workshop 8
No problem = no improvement: Lean tools, the LEAN mindset and concrete solutions to increase performance
Facilitators : Ronan LE FLOC'H - SANOFI & Jean-François BACHER & Laurent BOURDON - LEAN PERFORMANCE SAS
Moderator : Christophe MEUNIER - AKTEHOM
After a decoding of LEAN (reminder of episodes 1 and 2 = workshop 2019 and webinar 2020), the participants will integrate a pharmaceutical company in which problems are not solved .... It is up to you to solve them! The objective will be to find together the "right" LEAN tools to improve the company's performance!
Workshop 9
Regulatory developments, Annex 1, pharmacopoeias, latest technological advances: A fresh look at pharmaceutical water installations. From design to monitoring through the main KPIs
Facilitators : Aurélien PERIQUET - OCTAPHARMA & Samah RINGA - SUEZ
Moderator : Hervé TASSERY - 5M PARTNER
After a brief review of the regulations, the main points discussed will focus on the design of a water production facility for pharmaceutical use. The main technological choices will be detailed and justified.

The workshop part will consist of a reflection on the design of a complete system and the definition of the KPI allowing its piloting for a total control and a constant reliability.
Workshop 10
Interpretation of analytical validation data
Facilitators : Stéphanie PLOIX - LFB & Gérald DE FONTENAY - CÉBIPHAR
Moderator : Bénédicte GAS - CHARLES RIVER
The main objective of an analytical validation is to guarantee the reliability of the results that will be generated with this method.

The objective of this workshop will be to deepen the exploitation of the validation data, in order to extract the maximum amount of information that will be useful to the routine user of the method.

Faced with measurement uncertainty, the learning and use of various useful tools to make results in the laboratory more reliable will be shared with the participants (accuracy profile, prediction interval, replicate strategy, control strategy, drafting of operating procedures, etc.), through various examples and cases that we encounter on a daily basis in the laboratories.
Workshop 11
Controlling the risk of contamination is a matter of analysis and pragmatism!
Facilitators : Marie-Bénédicte TESSIER - VETOQUINOL SA & Sandrine DUCLOS - COPHACLEAN
Moderator : Didier MEYER - DMCOMPLIANCE
-Meeting the expectations of Annex 1

-Risk analysis to determine surface cleaning frequencies

-Trend analysis

-Pragmatic approach for daily application

-Feedback and case studies in sterile areas

-Subgroup work on the different themes
Workshop 12
Is CSA the future of CSV ?
Facilitators : Ken SHITAMOTO - GILEAD SCIENCES & Gai ANBAR - QUALITEST Group
Moderator : Jean-Louis Jouve - COETIC
Computer Software Assurance (CSA) is a US FDA Case for Quality initiative that arose when computer systems validation was identified as a barrier to adopting technology for modernization and innovation.

CSA is the application of critical thinking to validation that adds risk-based documentation to risk-based testing while taking a lifecycle approach, to “take credit” for activities, and reduce the validation effort. It is a “least burdensome approach” with the effort focused on risk to patient safety, product quality, and data integrity. During this workshop, we will provide an overview of CSA and explain CSA in the context of current regulations and GAMP. After the session, you will have the answers to questions such as:
-Can CSA be implemented until the guidance comes out ?
-Is CSA limited to medical devices because it is a CDRH concept ?
-Are screenshots always required as test evidence ?
-How does CSA impact quality ?
-Must automation and ancillary tools be qualified ?
-Can internal development testing be leveraged in validation efforts ?
-How can we leverage CSA to shorten release cycles ?

The workshop will answer all these questions and more within the context of examples and case studies from the field. Our goal is to provide the tools so you may begin your own CSA journey using the tools and techniques discussed during the session.
Workshop 13
Pivoting to be ready today and tomorrow
Facilitators : Dominique BEN DHAOU - POINT NORTH & Nicolas QUOEX- SKILLSPOTTING SA
Moderator : Anne HAYS - CARSO
In every difficult period, the way we manage can also be a source of success. Turning your business, your team and yourself around is about seeing the situation from a different perspective. This practical and interactive workshop will prepare you now to shift your mindset, your time, your resources, your team, your marketing and your business. Participants leave inspired with a concrete action plan.
Workshop 14
Designing a clean room for optimised contamination control, operator and environmental protection
Facilitators : Fabrice QUINSON - LSB & Philippe TAILLIEZ - ACM PHARMA
Moderator : Anne CASSART - LSB
Depending on the activities that are carried out in a controlled area and the protection conditions required, the design of the areas must meet requirements that are not always compatible with each other.

The workshop will be devoted to the analysis of specific and sometimes divergent constraints for the design of laboratory areas with very different activities (classes L 2 and L3). The concrete case presented will start from the theoretical outline of the need to the practical design of classified areas in a complex building, up to its realization and qualification.

The objective of the workshop is to show the importance of an upstream integration of the different participants: Architects-engineering-HVAC-Envelope (floor, panels, furniture, doors, airlocks) up to the final qualification in a serene and confident Client-Supplier relationship.

The work that will be carried out in groups during the workshop will enable the various pitfalls of such an approach to be evaluated, the possibilities for gains in efficiency, cohesion between suppliers and service limits to guarantee the control of the production environment in the long term.
Workshop 15
Student workshop : A day of immersion in the pharmaceutical industry: EPPI water, environment and ZAC, control and quality, regulations ...
Facilitators : Bruno TISSIER - TISSIER PHARMA CONSULTING & Jerome DONON - A3P ASSOCIATION
Moderator : François MOREL - A3P ASSOCIATION
The objective is to review fundamental specificities of the pharmaceutical industry and essential for future managers or executives in practice. This workshop will develop essential topics. Exchanges with exhibitors on the stands will illustrate the presentations made. The subjects covered will be: water and its various pharmaceutical qualities, air treatment in clean rooms (laminar flow, isolators, RABS), structures of controlled environments (partitions, ceilings, airlocks, etc.), control laboratories (quality control, physico-chemistry and microbiology) and the regulatory aspect (GMP, ICH, FDA, etc.). Contacts will also be made with suppliers.
This workshop is aimed primarily at A3P Tremplin students but also at industrialists or suppliers who would like to review certain fundamentals
Workshop 16

If you wish to reserve a stand, please contact us :

lbayle@a3pservices.com

Exhibition map

Companyn°stand
AEROMETRIKO6
AKTEHOMO18
ALBHADESR21
ALFA LAVALR15
AMSONIC – HAMOR23
ASEPTIC PROCESSF8
ASEPTIC TECHNOLOGIESK5
ASSOCIATES OF CAPE CODO36/O37
ATEC PHARMATECHNIKB1
AZBIL TELSTAR FRANCEO31
BACCINEXO13
BATIMPROR12
BECKMAN COULTERO22
BIOMÉRIEUXO43/O44
BIOPHARMA TECHNOLOGIES FRANCEB2
BIOQUELLO32/O33
BWTO42
CARBOGEN AMCISO38
CARSOR9
CHARLES RIVERR25/R26
CHRISTEYNS LIFE SCIENCESF4
CMIO14
CONFARMA FRANCEF2
CONFORMATK3
CONTEC INCO9
COPHACLEANO48
DEVEA ENVIRONNEMENTR22
ELIS CLEANROOMO24/O26
ELLABK4
ENDRESS+HAUSERF16
ENTEGRISO2
ERTEC CLEANROOMK2
GIVE & TECHO4/O5
GOMETROLOGIEK13
HAMILTON BONADUZR28
ICAREO11
IDEC SANTEF5
ILC DOVERF10
IMA FRANCER4
INITIAL CLEANROOMSO30
INTERSCIENCEF12
INTERTEK FRANCEO27
IWT CLEANING EXCELLENCEO42BIS
JCE BIOTECHNOLOGYO52
KAYEKO1
KÖRBER PHARMAO19
LABORATOIRES ANIOS an ECOLAB CompanyF11
LABORATOIRE HUCKERT’SF7
LAPORTE EUROR27
LDI-BOURSIER SOGREGO21
LIVES INTERNATIONALK7
LONZAO45
LSB – LA SALLE BLANCHER32
LUCISBIOO12
MERCKF13/F14
MESA FRANCER30
METTLER TOLEDO THORNTONO29
MIRRHIAO41
NOVATEK INTERNATIONALR20
OPTIMA PHARMAO46
OXY’PHARMO3
PALL BIOTECHO16/O34
PAMASF1
PARKER HANNIFIN FRANCER5
PFEIFFER VACCUMO7
PHARMAPLANR24
PHARMASEPF6
PHARMTECO17
PMT FRANCEO23
RAPID MICRO BIOSYSTEMSO28
REALCOR14
ROMMELAG AGR8
RT2IK1
SALAMANDERUF9
SARTORIUSO1
SCHOTTO20
SCHREINER MEDIPHARMO49
SCHÜLKE FRANCEO51
SGS FRANCEO50
SIDJIO8
SKAN GROUPF3
SOFASTR29
SOLIDFOG TECHNOLOGIESR31
EN COURS DE RESERVATIONO47
STERIGENEO25/R1
STERIS LIFE SCIENCESR16/17/18/19
EN COURS DE RESERVATIONF15
SWANR3
SYMBIOSE ENVIRONNEMENTF17/F18
SYNTEGON TECHNOLOGYO39
TECHNIP ENERGIESR6
TECHNOCHIMR11
TEG / PROSYSR10/R10BIS
TERANGA GROUPEO15/O35
THERAXELR13
VENAIRO10
VEOLIA WATER TECHNOLOGIESR2
VWR PART OF AVANTORO40
WILCO / BAUSCH + STRÖBELR7
AVAILABLE STANDS
Currently bookedK6
K8
K9
K10
K11
K12
KO2
KO3
KO4
Currently bookedKO5

Booth available for booking:

> Kiosk

Services included with the Kiosk:

  • 1 kiosk including the registration of an exhibitor (2900€ excl. tax)
  • 2 melamine panels of 1m x 2.5m on which your visuals of your choice are printed
  • 11 shelf of 2m x 0,3m fixed to put documents.
  • Flag sign for inscription of exhibiting company name and stand number
  • 1 electrical connection
  • 1 Nespresso coffee machine
  • 1 high stool
  • Unlimited wifi access
  • 1 trash can
  • The possibility to register a stand companion at the rate of 690€ excl. tax

Registration form

 A3P International Congress

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

Registration fees : 1275€ excl. tax  + Mandatory A3P membership 220€ excl. tax // (VAT 20%)

Contact

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

Phone number : +33 (0)4 37 28 30 40
Fax : +33 (0)4 37 28 30 60
Email : lbayle@a3pservices.com – nsemedo@a3pservices.com
Postal address : A3P, 30 rue Pré-Gaudry – Lyon 69007

Accessibility

Hotel booking

[HOTELS]