Espace Bellevue, Biarritz
23, 24 and 25 November 2021
Save The Date !
Conferences, workshops, exhibition
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
GIC A3P Single Use Representatives
GIC A3P Single Use Representative
GIC A3P Single Use Representatives
Wednesday 24 November
Thursday 25 November
- Abdelaali SARAKHA - Senior GMP GMP/GDP inspector - ANSM
- Sophie AMADIO - QA Consultant - LILLY
- James DRINKWATER - Head of PHSS Aseptic Processing and Containment Special Interest Group - PHSS
- Jean-François DULIERE - Regulatory Advisor - ISPE
- Di MORRIS - Clinical Auditor - ASTRAZENECA
- Julien TRIQUET - Sterility Assurance Director - GSK VACCINES
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.
-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)
-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
-Process validation: the three stages of validation according to the life cycle of medicines
-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.
Annex 1 Draft V12 introduced this CCS principle with the intent to structure the prevention of contamination based on Quality Risk Management; from facility & process Design, execution/organisation of the operations and finally guarantee the adequate controls are in place with the objective to continuously improve sterility assurance. Though the principle of contamination controls and process performance was always a priority for manufacturers, the documentation of the CCS remains a challenge, as multiple ways are possible to build this principle.
This workshop will provide the opportunity for attendees to obtain the information on an ongoing initiative to define a guidance to structure CCS (A3P/PHSS collaboration) and to apply this guidance approach for different parts of sterile manufacturing.
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.
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
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.
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.
-Risk analysis to determine surface cleaning frequencies
-Pragmatic approach for daily application
-Feedback and case studies in sterile areas
-Subgroup work on the different themes
-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.
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.
This workshop is aimed primarily at A3P Tremplin students but also at industrialists or suppliers who would like to review certain fundamentals
|AMSONIC – HAMO||R23|
|ASSOCIATES OF CAPE COD||O36/O37|
|EREA CLEAN AIR SYSTEMS||K10|
|GIVE & TECH||O4/O5|
|IWT CLEANING EXCELLENCE||O42BIS|
|KAYE – AMPHENOL||KO1|
|LDI BOURSIER SOGREG||O21|
|LSB LA SALLE BLANCHE||R32|
|PHARMAPLAN (TTP GROUP)||R24|
|RAPID MICRO BIOSYSTEMS||O28|
|SGS HEALTH SCIENCE||O50|
|STERIS LIFE SCIENCES||R16/17/18/19|
|SYSTEM C BIOPROCESS||KO4|
|VEOLIA WATER TECHNOLOGIES||R2|
|WILCO / BAUSCH + STRÖBEL||R7|
Booth available for booking:
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
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%)
Depending on your requirements and preferences, you can contact Ludivine BAYLE (exhibition) or Natalina SEMEDO (programme & registration) :
A3P free shuttles
Free shuttles are at your disposal during the congress (Airport <->Bellevue and Railway station <-> Bellevue)
|Monday, November 22|
|Airport -> Bellevue||08:00 to 09:00|
14:30 to 15:30
17:30 to 18:30
20:00 to 21:00
21:45 to 22:45
railway station -> Bellevue
14:00 to 15:00
|Tuesday, November 23|
|Airport -> Bellevue||08:00 to 08:30|
09:00 to 09:30
|Thursday, November 25|
|Bellevue -> Airport||12:00 to 13:00|
15:00 to 17:00
|Bellevue -> Railway station||12:00 to 13:00|
Air France Flights
Attractive discounts, up to -15%, on a wide range of public fares on all AIR FRANCE, KLM and their code-shared flights worldwide.
Event: Congrès A3P Biarritz 2021
ID Code: 37743AF
Travel Valid Period: 05/11/2021 to 10/12/2021
Event location: BIARRITZ-BAYONNE
Please visit the event website or access directly through https://globalmeetings.airfranceklm.com/search/promodefault.aspx?vendor=AFR&promocode=37743AF