Join the must-attend event of the profession, by joining More than 750 makers in the pharma industry during 3 days.
At the next A3P International Congress, the conferences will allow you to supervise the quality of your productions & controls from the "Contamination Control Strategy" to the visual inspection to be in a position of excellence during regulatory inspections.
As for the workshops on Wednesday, they will address specific topics in front of a participative audience by mixing theory and practice with among others the utilities (water and gas), the cleanings, the new technologies (SUT) and the integrity of the data.
See you for this 31th congress, during which your participation will allow the technological advances of clean and sterile!
The purpose of the workshops is to sensitize or deepen theoretical or practical notions using case studies that participants must address during a workshop in order to propose solutions in the form of conclusions, written with the help of the facilitators. -experts
Break - Visit of the exhibition
Continuation of the first part of the workshop
Lunch cocktail in the exhibition
Second part of the workshop
Break - Visit of the exhibition
Continuation of the second part of the workshop
End at 18h
Thursday October 17
Welcome of participants
Presentation of the topic "Contamination Control Strategy"
Antoine AKAR - GSK VACCINES
Control Strategy for Contamination and Cross Contamination Control in Manufacture of Medicinal Products
Di MORRIS - GSK
Feedback on the control of insulator contamination for the production of advanced therapy medicinal products for veterinary use
Helene GRAID - REVATIS
Break on the exhibition / Meeting and dedication with François MOREL on the stand A3P
Presentation of an approach to control microbiological contamination in a biotech process up to Drug Substance stage (non-sterile DS - "low bioburden" approach)
Johanne PIRIOU & Camille LANDRIEU- AKTEHOM
Environmental Control of ZACs and Microbiological Traceability
Fabian GUISSET & Rémy SAGOT - BIION
Contamination control strategy - Validation of cleanroom clothing
To sensitize or to improve theoretical or practical notions using case studies that participants must address during a workshop in order to propose solutions in the form of conclusions, drafted with the help of the expert-facilitators. The group of the workshop consists of an A3P manager (or moderator) from the Board of Directors, two animators chosen for their recognized skills (1 manufacturer and 1 supplier) and delegates or exhibitors who have registered by name. During a day, the participants will exchange, work and debate around a technical or regulatory theme.
Wednesday 16 October - Workshops
Investigate deviations based on real cases, resolve regulatory discrepancy and answer to inspection observations related to sterile / aseptic field
This workshop is proposed to discuss various topics with a specific focus on EU GMP Annex 1. Throughout the workshop: Four different observations Authorities (ANSM, EMA or US FDA) will be aseptic / sterile aspects and two real case studies (environment, manufacturing tools, aseptic behavior, water loops, ...).
This workshop is intended for anyone involved in aseptic / sterile field. It will allow participants to discover various situations that can take place everywhere, even "at home" ... Under realistic conditions, the workshop will lead participants to conduct an investigation, to seek together not only the causes, but also the root causes of the deviation in order to prevent them efficiently. For this purpose, suggestions arising from root causes will be proposed. The workshop will be broken down, whenever it is possible, to illustrate the experience of the future review of the contamination control strategy.
Management of cleaning, disinfection, sterilization and aseptic assembly for all surfaces and equipment of an aseptic filling line in RABS and isolator
Animators: Adrien RAULT - SANOFI & Pierre DEVAUX - THERAXEL - POINT FORTY FIVE
Moderator: Thierry BONNEVAY - SANOFI
The workshop will review the regulations in relation to the different possible configurations. We will talk about the format pieces, the plug feeding bowls and all the parts in indirect contact on the filling line, like the accumulation tables of the bottles at the end of the depyrogenation tunnels but also the gloves and the cuffs for example . The idea is to set up a sterilization disinfection cleaning strategy for all surfaces under an injectable filling line, including the product line and cross-check this with the requirements of the 15 Annex and also talk about the possibility of using Single Use.
We will propose practical exercises for the different surfaces concerned.
Off-specification and out-of-trend results (OOS - OOT) at the control laboratory, context, management and treatment
The first part of the workshop will describe current regulatory requirements for defining out-of-specification, out-of-range and out-of-trend results and their commentary. After the definition of the different types of out-of-specification or out-of-range results expected depending on the type of test and the context, a review of the available documentation on the subject will be carried out. The participants will then work in groups on concrete cases of OOS / OOT analytical or microbiological results. They will carry out the investigative process in the laboratory taking into account the regulations in force and the European and American guides. Concrete examples submitted by participants at the time of registration will be processed by the groups.
A day of immersion in water, environment, control and quality, regulation
Animators: Jérôme DONON & François MOREL - A3P
Moderator: Bruno TISSIER - A3P
The objective is to return to the fundamental peculiarities 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 topics will be: water and its different pharmaceutical qualities, air treatment in clean rooms (laminar flow, insulators, RABS), structures of controlled environments (partitions, ceilings, airlock, ...), laboratories control (quality control, physico-chemistry and microbiology) and the regulatory aspect (GMP, ICH, FDA, ...) Industrialists will also discuss their professional experience. Contacts will also take place with suppliers.
Pharmaceutical Water & Pure Steam System in a Regulatory News (2017 Revision of European Pharmacopoeia for BWFI, 2019 EMA EU-GMP Revised Annex1, 2019 EMA Revised Guideline on the Quality of Water for Pharmaceutical Use)
Animators: Paolo CURTO - DOC & Bruno MARAVAL - SANOFI GENZYME
Moderator: Robert NERI - ROBERT NERI CONSULTING
Presentation of Regulatory & GMP Requirements of Pharmaceutical Water & Pure Steam Systems; Presentation of Validation Life Cycle of Pharmaceutical Water & Pure Steam Systems; Focus on Revised EP Monograph (0169) for WFI production (2017) Focus on Revised EMA EUGMP Annex 1 (2019) exploring the Regulatory & Technological Impact on current application; Focus on Revised EMA Guideline on the quality of water for Pharmaceutical Use (2019) All above point 3, 4 and 5 will be translated into class. The language of Mr. Paolo Curtò training material is in english but during workshop and Question / answers Mr. Robert NERI will be facilitating the workshop speaking in French.
Single Use Technology (SUT) versus non-dedicated conventional equipment: what about the strategy of contamination control. Are SUTs the solution or do they bring other concerns / constraints?
Animators: Etienne MICHEL - GSK VACCINES & Robin BIGOT - COPHACLEAN
Moderator: Didier MEYER - DMCOMPLIANCE
Recap of the 7 2018 Workshop Conclusions as a Basis for the XNUMX Workshop
Regulatory Reminder on Contamination Control and Return Inspection
- Deployment of a risk analysis concerning the integration of Single-Use in the equipment train and what about the contamination, extractable ...
- Stress assessments under the contamination control angle of such an approach,
- Proposal of a pragmatic strategy
Panorama of digital solutions used in pharmaceutical factories. Example of concrete cases, feedback, practice
Digital, Digital, Digital. This term is heard everywhere but what is the situation today in pharmaceutical factories? Which solutions are really operational, useful for the teams and for which benefits?
The participants will discover the solutions deployed on the industrial sites and will work in groups to complete their knowledge. 3 concrete cases of interest to the industry will be presented:
- Digital training and virtual reality for operators
- e SOP for QC laboratories
- Electronic batch file for production
During the morning, in the introduction, the presenters will present an overview of the quality and regulatory solutions and pre-requisites for such projects, as well as the key success factors in project management and change management. This introduction will be based on feedback.
At the end of the morning and during the afternoon, each participant will join a subgroup:
- Digital training: the group will define the approaches and solutions to train operators in Class A / B
- QC 4.0: The group will offer augmented reality applications, connected operators, data analytics and artificial intelligence for QC laboratories
- Electronic batch file: the group will work on the preparation of an electronic batch file project.
The facilitators will assist the subgroups through pedagogical and fun approaches and through their knowledge. Each group will give a summary of its work to all participants.
This workshop is aimed at production, quality, CQ, engineering, HR and site management managers; who will be able to participate in the subgroup in relation to their functions and aspirations. Participants will acquire knowledge that they can apply in their societies. Strong emphasis will be placed on interaction, creativity and sharing among participants.
How to prepare for an inspection on the subject "Data Integrity"?
The integrity of the data integrity ("Data Integrity") is a joint concern of the authorities and the health industries. While many experts agree that most aspects related to "Data Integrity" are not new topics, the focus of different regulatory bodies on this topic has the merit of questioning certain practices that could vary with time and technological developments.
The workshop aims to clarify regulatory expectations and provide participants with a pragmatic approach to preparing for regulatory inspections or customer audits on these topics.
Utilizing Six Sigma, methods to create a Data Integrity Strategy
Animators: Jordi IGLESIAS - CHARLES RIVER & Hugues DESREUMAUX - GUERBET
Moderator: Bénédicte GAS - CHARLES RIVER
Six Sigma methods have a long history of problem solving, standardize their processes, and positively impact product quality.
Through this interactive session, we will seek to provide guidance on
- Utilizing an organized, risk-based approach to closing human error in your processes.
- Examining real-world examples from the industry for the evaluation of your own processes.
New technologies play an important role in reducing a laboratory
Construction of a LEAN approach: from strategy to operational deployment.
Animators: Jean-François BACHER - LEAN PERFORMANCE SAS & Yannig BONNINGUE - LEAN PERFORMANCE SAS & Ronan LE FLOC'H - SANOFI
Moderator: Christophe MEUNIER - AKTEHOM
After a decoding of the LEAN, participants will discuss concrete examples of the application of LEAN in various industries: automotive, pharmaceutical, aeronautics, heavy, ... including support functions, and their transposition in pharmaceutical environment. A simulation game will concretely illustrate the impact of a LEAN approach. The participants will leave with the key information:
- the conditions of success of an approach,
- brakes and risks,
- the impacts, positive and negative,
- the golden rules of the Lean attitude.
Pharmaceutical gases: towards the implementation of a quality monitoring similar to that of Waters
As an ingredient or as a utility (transfer or inerting fluid for example), the quality of the gas in contact with the product must be controlled in the same way as the raw materials, the pharmaceutical waters or the direct environment.
- Industrial context and regulations
- Recall on the repositories
- Critical Utilities: What Consequences of the 1 Appendix?
- Need for microbiological qualifications and analytical controls (identification / purity)
- Qualification Strategy / Qualifications
- Routine and follow-up
- Points of vigilance associated with the design of installations (feedback)
- Maintenance (feedback)
- Periodic qualification activities and routine monitoring of a compressed air & nitrogen network for a pharmaceutical production unit
- Presentation of control equipment and methods
- Compilation and analysis of results
- Workshop: work on an example of sampling / periodic qualification strategy, treatment of nonconformities, trend analysis ... ..
- Questions answers
Visual inspection: our daily questions!
Animators: Jean Michel TASSERIT - CENEXI & Stéphanie BUTON - ASSYSTEM CARE
Moderator: Patrick MAHIEUX - ABL EUROPE
Injectable products require an increasingly sophisticated visual inspection, a step in the process that is essential and necessary for the safety of the patient and therefore highly regulated. Through this workshop, we will address both the strategic approaches related to the mirage technique and the multiplicity and specificity of products. When the arrival of a new product, which did not have the following questions: How to make this product a little special? What additional training for my operators? What impact on my default? ... Based on our experience on a multitude of products (biotech or chemical, powder or liquid, colored, opalescent, adsorbed, combined products ...), we will discuss in particular the criticality of defects, the process of enabling operators, the constitution Training and habilitation kits, the evolution of the defaults by integrating the contributions of the USP 1790.
The validation of analytical methods in 2019, for a pragmatic consideration of the latest developments ICHQ2 FDA USP
Facilitators: Gerald DE FONTENAY - CEBIPHAR & Thomas MIRIBEL - DEBIOPHARM
Moderator: Pierre ANDRE - GUERBET
The world of analytical validation is once again in full swing and raises many questions: - How to react in a pragmatic way to these changes? - What are the real expectations of ICH and the authorities? - How to manage the method validation and the interpretation of the results? Faced with these many questions and after the presentation of the context by the facilitators, the participants discuss their different approaches to meet these new requirements.
Application of the QRM concept to the design and qualification of classified premises
The concept of QRM developed in ICHQ9 is no longer a novelty! Since 2015, GMPs focus on the use of Quality Risk Management (QRM). Moreover, this principle has been enormously highlighted in the draft of the future Annex 1. As part of the design, classification and qualification of classified areas, this QRM principle is to be applied. We propose in this workshop to study in session the practical implementation of a risk analysis approach applied to a product formulation workshop before aseptic filling. The scope of the analysis concerns classified premises. Several risk analysis methods will be proposed to evaluate their relevance according to the situations to be treated. The participants will have to decline on the practical case presented to design the premises, define the means of cleaning and their frequency, and propose tests and criteria of qualification and validation of cleaning adapted for these premises.
Animators: Jim POLARINE Jr - STERIS & Benoit RAMOND - SANOFI
Moderator: Alain RACHON - MERCK
This workshop covers contamination control in cleanrooms applied to sterile processes using a good science based approach. Environmental monitoring, Risk based analysis, Viable and non-viable contamination in cleanrooms, Process design including barrier technologies, Cleaning and disinfection, Aging facilities, Fungal & spore forming organisms, Viral safety, Data integrity, Quality Systems & Quality Assurance, Disinfectant selection & testing. This workshop will help you to improve your knowledge of contamination control through case studies, feedback of experiences, audience interaction in groups, and a Jeopardy game based on contamination control.There will be a lot of audience participation and interaction related to contamination control regulations (eg Annex 1). There will be some critical thinking and risk based analysis of case studies and contamination issues in the cleanroom industry. CAPA investigation will be discussed.