A3P International Congress
Contamination Control Strategy - Visual Inspection - Preparation and Returns on Regulatory Inspections

Place

Bellevue Space

Biarritz

Dates:

15, and October 16 17 2019

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Format

Conferences, workshops, exhibition

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Tuesday October 15

Welcome of participants
08:00
Introduction
08:50
Presentation of the subject: visual inspection
To be confirmed
09:00
Automatic Visual Inspection of Lyophilized Products, Characterizes as Difficult to Inspect Products (DIP), with very low false reject
Andrea SARDELLA - STEVANATO Group & Guillaume GENTY - STERIGENE
09:15
Implantation of a first automatic mireuse at a CDMO - A feedback from experience
Anthony JOBLON & Jonnathan TAFFORIN - RECIPHARM MONTS
09:45
Break - Visit the exhibition
10:15
Process monitoring and integration
Valerie RAUTUREAU - LILLY
11:15
Mirage: main findings concerning ANSM inspections
MSNA
11:45
Lunch
12:15
Presentation of the subject: Preparation and return of regulatory inspections
Alain EUZEN - AXYS NETWORK
14:15
Inspections - feedback from international experience, situation in France and prospects for evolution.
Patrick TURLIER - PHARMA CONSULT TURLIER & Anne CARPENTIER - LEEM
14:30
How to prepare an inspection of Chinese health authorities in Europe?
Anouk CLOAREC - SANOFI
15:15
Break - Visit the exhibition
15:45
How to make an inspection?
Myriam BALME VERNAZ - AQ3D Performance / Gazpac & Luc CHARLES - LC Consultants
16:45
And if we were talking about preparation for inspection at a Pharmaceutical production site "inspection readiness!"
Corinne POULAIN - ASPEN
17:15
Why does the interpretation of inspection remarks prevent the development of the efficiency of quality systems and how to remedy them?
Arnaud HUC - Academy of Effective Quality
17:45
Cocktail exposure
18:30

Wednesday October 16

A3P Women Breakfast at the Municipal Casino
07:30
Reception of participants at Espace Bellevue for workshops
09:15
First part of the chosen workshop - See the proposed workshops
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
09:30
Break - Visit the exhibition
10:30
Resumption of the first part of the workshop
11:30
cocktail buffet on show
12:30
Second part of the workshop
14:00
Break - Visit the exhibition
16:00
Resumption of the second part of the workshop
End to 18h
16:30
Gala dinner
20:00

Thursday October 17

Welcome of participants
08:30
About the topic: Contamination Control Strategy
Antoine AKAR - GSK VACCINES
09:00
Control Strategy for Contamination and Cross Contamination Control in Manufacture of Medicinal Products
Di MORRIS - GSK
09:15
Feedback on the control of isolator contamination for the production of advanced therapy medicinal products for veterinary use.
REVATIS, SALAMANDERU, SOLIDFOG TECHNOLOGIES
09:45
Break - Visit the exhibition
10:15
Presentation of an approach to control microbiological contamination in a biotech process up to the Drug Substance stage (non-sterile DS - "low bioburden" approach)
Johanne PIRIOU - AKTEHOM & Stéphanie MONCHAUX - NOVARTIS
11:15
What future for environmental monitoring? An opportunity to create value beyond the regulatory constraints
To be confirmed
11:45
Contamination control strategy - Validation of cleanroom clothing
Steve MARNACH - DUPONT OF NEMOURS
12:15
Congress Lunch and Closing A3P 2019
12:45

What is a workshop?

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
09h30
Investigation based on real cases, resolving regulatory discrepancy and answer to inspection observations related to sterile / aseptic field.
Animators: Olivier CHANCEL - MERIAL & Walid EL AZAB - STERIS
Moderator: Sophie AMADIO - LILLY
This workshop is proposed to discuss various topics with a specific focus on EU GMP Annex 1. Throughout the workshop:

- Four different Authorities observations (ANSM, EMA or US FDA) will be shared as part of the process of making observations 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.
1 workshop
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: Sonia KASPEROWICZ - GSK
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 Annex 15 and also talk about the possibility of using Single Use.

We will propose practical exercises for the different surfaces concerned.
2 workshop
Off - specification and out - of - trend results (OOS - OOT) at the control laboratory, context, management and treatment.
Facilitators: Sandra PERIDY - ACMPH & Guillaume PINON - FAMAR
Moderator: Eric PETAT - TERANGA GROUP
The first part of the workshop will be devoted to describing current regulatory requirements for defining out - of - specification, out - of - range and out - of - trend scores 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.
3 workshop
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.
4 workshop
PHARMACEUTICAL WATER & PURE STEAM SYSTEM IN LIGHT OF RECENT 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
1. Presentation of Regulatory & GMP Requirements of PHARMACEUTICAL WATER & PURE STEAM SYSTEMS;

2. Presentation of Validation Life-cycle of PHARMACEUTICAL WATER & PURE STEAM SYSTEMS;

3. Focus on Revised EP Monograph (0169) for WFI production (2017)

4. Focus on Revised EMA EUGMP Annex 1 (2019) exploring the Regulatory & Technological Impact on current application;

5. Focus on Revised EMA Guideline on the Quality of Water for Pharmaceutical Use (2019) exploring the Regulatory & Technological Impact on current application;

6. All above point 3, 4 and 5 will be translated into class;

7. The language of M. Paolo Curtò

Mr. Robert NERI will be facilitating the workshop speaking in French.
5 workshop
Single Use Technology (SUT) versus non-dedicated conventional equipment which is the strategy of control of contamination. 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

Practical case:

- 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
6 workshop
Panorama of digital solutions used in pharmaceutical factories. Example of concrete cases, feedback, practice.
Animators: Adeline TERRIAC - ALTRAN & Xavier LOPEZ - SANOFI & Borja TINAO - ALTRAN
Moderator: Jacques NAVELLOU - AXYS NETWORK
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

In the morning, the speakers will present a summary of the solutions and quality and regulatory requirements 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 educational 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 sub-group 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.
7 workshop
How to prepare for an inspection on the subject "Data Integrity"?
Animators: Hervé CLUZEAU - ASSYSTEM & Sylvain PLAGELLAT - MERCK
Moderator: Jean-Louis JOUVE - COETIC
The integrity of the regulated data ("data integrity") is a joint concern of the authorities and the health industries; While many experts agree that most aspects of data integrity are not new subjects, the focus of the various regulatory bodies on this subject has the merit of calling into question 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.
8 workshop
Using 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
9 workshop
Construction of a LEAN approach: from strategy to operational deployment.
Animators: Jean-François BACHER - LEAN PERFORMANCE SAS & Yannig BONNINGUE - LEAN PERFORMANCE SAS & Ronan LE FLOCH - SANOFI
Moderator: Christophe MEUNIER - AKTEHOM
Exchanges with participants of successes, difficulties in setting up a LEAN / Operational Excellence approach.

After a decoding of the LEAN, the participants will exchange around concrete examples of the application of LEAN in the operational sectors [production, quality, supply chain, ...] and also around concrete examples of the application of the LEAN office in the project management or support functions.

Real case study from the pharmaceutical, aeronautics, automotive, heavy industries .... The participants will share in subgroups to identify the obstacles to change and define the keys to success of a sustainable LEAN approach. "

The deliverable: a practical guide to starting a structured approach.
10 workshop
Pharmaceutical gases: towards the implementation of a quality monitoring similar to that of Waters
Animators: Corinne COMPS - BOEHRINGER-INGELHEIM & Guillaume LEDOUX - EUROFINS
Moderator: Arnaud CARLOTTI - EUROFINS
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 Annex 1?

- Need for microbiological qualifications and analytical controls (identification / purity)

- Qualification Strategy / Qualifications

- Routine and follow-up

- points of vigilance associated with the design of the 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
11 workshop
Visual inspection: our daily questions!
Animators: Jean Michel TASSERIT - CENEXI & Stéphanie BUTON - ASSYSTEM CARE
Moderator: Patrick MAHIEU - 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 the 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? ...

With 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 empowering operators, the constitution of Training and habilitation kits, the evolution of default systems by integrating the contributions of USP 1790.
12 workshop
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 pragmatically 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.
13 workshop
Application of the QRM concept to the design and qualification of classified premises
Animators: Isabelle SARFATI - LFB & Estelle DARNON - TECHNIPFMC
Moderator: Jonnathan TAFFORIN - RECIPHARM
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.

- In this workshop, we propose to study 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 methods of risk analysis will be proposed to assess 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.
14 workshop
Workshops' end
18:00

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

Download the PDF file

Plan of the exhibition

CompanyNo. Stand
ADS LAMINARR20
AlbhadesR21
AMPHENOL ADVANCED SENSORSKO1
AMSONIC HAMOR23
APSALYSO6
ASEPTIC TECHNOLOGIESK5
ASSOCIATES OF CAPE CODO36 / O37
B.BRAUN MEDICALR11
BATIMPROR13
BCMIK1
BECKMAN COULTERO22
BIION MIRRHIAR32
BIOMERIEUXO43 / O44
BIOQUELLO32 / O33
BOSCH PACKAGINGO39
SOGREG STOCK EXCHANGERB1
BRUKER FRANCEK3
BWTO42
CARBOGEN AMCISO38
CARSOR9
CHARLES RIVERR25 / 26
CHRISTEYNSF4
CMIO14
CONFARMA FRANCEF2
CONTECO9
COPHACLEANO48
DECON-O-LOGICO10
DUPONT DE NEMOURSF7
ELISO24 / O26
EllabK4
EMERSONR14
ENDRESS + HAUSERF16
ENTEGRISF6
Eurofins BPTR5
GEA PROCESS ENG.O13
GETINGE FRANCER10
GIVE & TECHO4 / O5
ICARUSO11
IDEC HEALTHF5
ILC DOVERF10
IMA FRANCER4
INITIAL CLEANROOMSO30
INTERSCIENCEF12
INTERTEK FRANCEO27
IONISOSO21
JBT HUB UPR28
JCE BIOTECHNOLOGYO52
KIMO INSTRUMENTSO2
THE WHITE ROOMO41
LABORATORIES ANIOSF11
LAPORTE EUROR27
LevitronixK2
INTERNATIONAL LIVESF8
Lonza COLOGNE GMBHO45
LUCISBIOO12
MATACHANA FRANCEKO3
MEDIPAK SYSTEMSO19
MERCKF13 / F14
MESA FRANCER30
METTLER THORNTONO29
NNER24
NOVATEK INTERNATIONALKO2
OPTIMAO46
PALL BIOTECHO16 / O34
PAMASF1
PFEIFFER VACUUMO7
PHARM ALLIANCE / COMECERO3
PHARM'ADISR22
PHARMTEC TOFFLONO17 / O18
PMS FRANCE BENELUXO20
PMT FRANCEO23
Rapid Micro BiosystemsO28
RAUMEDIC AGR29
ROMMELAG AGR8
SALAMANDERUF9
SARTORIUS STEDIMO1
SCHREINER MEDIPHARMO49
SCHÜLKE FRANCEO51
SGS LIFE SCIENCEO50
SidjiO8
SKAN GROUPF3
SOFASTKO4
SOLIDFOGR31
SPC GROUPR12
SPIER15
STERIGENEO25 / R1
STERIS R16 / 17 / 18 / 19
SUEZF15
SWANR3
SYMBIOSE ENVIRONMENTF17 / F18
TECHNIPFMCR6
TechnochimKO5
IWT CLEANING EXCELLENCEO47
TEGB2
TELSTARO31
TERANGA GROUPSO15 / O35
VEOLIA WATER STIR2
VWR PART OF AVANTORO40
WILCO AGR7
K7
K8
K9
K10
K11
K12
K13

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Congress A3P 2017 - 14 16 in November in Biarritz

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Contact

Depending on your requirements and your preferences, you can contact Ludivine BAYLE (exhibition) or Natalina SEMEDO (conferences / registrations):

Phone: +33 (0)4 37 28 30 40
Fax: +33 (0)4 37 28 30 60
E-mail : lbayle@a3pservices.comnsemedo@a3pservices.com
Mail: A3P, 30 rue Pré-Gaudry - Lyon 69007
On site: 30 rue Pré-Gaudry, Lyon, from Monday to Friday

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