Save the date !
Tuesday October 15
Wednesday October 16
Thursday October 17
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.
- 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.
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.
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.
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.
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
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.
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.
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
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.
- 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
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.
- 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.
- 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.
Plan of the exhibition
|AMPHENOL ADVANCED SENSORS||KO1|
|ASSOCIATES OF CAPE COD||O36 / O37|
|BIOMERIEUX||O43 / O44|
|BIOQUELL||O32 / O33|
|SOGREG STOCK EXCHANGER||B1|
|CHARLES RIVER||R25 / 26|
|DUPONT DE NEMOURS||F7|
|ELIS||O24 / O26|
|ENDRESS + HAUSER||F16|
|GEA PROCESS ENG.||O13|
|GIVE & TECH||O4 / O5|
|JBT HUB UP||R28|
|THE WHITE ROOM||O41|
|Lonza COLOGNE GMBH||O45|
|MERCK||F13 / F14|
|PALL BIOTECH||O16 / O34|
|PHARM ALLIANCE / COMECER||O3|
|PHARMTEC TOFFLON||O17 / O18|
|PMS FRANCE BENELUX||O20|
|Rapid Micro Biosystems||O28|
|SGS LIFE SCIENCE||O50|
|STERIGENE||O25 / R1|
|STERIS||R16 / 17 / 18 / 19|
|SYMBIOSE ENVIRONMENT||F17 / F18|
|IWT CLEANING EXCELLENCE||O47|
|TERANGA GROUPS||O15 / O35|
|VEOLIA WATER STI||R2|
|VWR PART OF AVANTOR||O40|
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 : firstname.lastname@example.org – email@example.com
Mail: A3P, 30 rue Pré-Gaudry - Lyon 69007
On site: 30 rue Pré-Gaudry, Lyon, from Monday to Friday