Save The Date !
The situation related to Covid-19 does not allow us to date to guarantee a quality live event. For this reason, a digital solution is proposed for the whole program of the A3P Congress (conferences and workshops). The A3P Association continues to be committed to its network and remains focused on its primary mission: to connect manufacturers and suppliers through technical and regulatory issues.
The conference program is divided into 3 sessions according to the thematic (1/2 day) :
- Control strategy (Process & Analytical and Life cycle) / 18 nov.
- QRM for parenteral processes / 24 nov.
- Annex1 GMP EU V12 2020 / 25 nov.
The workshops have been reshaped to adapt to the digital format, and spread over 4 half-days. This will allow you to participate in several workshops according to the themes of your choice! 😊
- Abdelaali SARAKHA - Senior GMP GMP/GDP inspector - ANSM
- Alan MOON - Senior GMDP Inspector - MHRA
- Matt DAVIS - Senior GMP Inspector - PIC/S TGA (Therapeutic Goods Administration)
- James DRINKWATER - Head of PHSS Aseptic Processing and Containment Special Interest Group - PHSS
- Joerg ZIMMERMANN - Vice Chair, International Board of Directors - ISPE
- Representatives of the WGI A3P Annex1 : Nicolas BOURGEOIS - GSK Vaccines & Pierre DEVAUX - THERAXEL & Sandrine FAVRE - OCTAPHARMA & Julien TRIQUET - GSK
Agenda of the virtual WORKSHOPS of the A3P 2020 Congress
16 sessions of digital workshops will be proposed to you over 4 half-days. The opportunity to participate in several sessions according to your themes of interest and to benefit from the expertise of our facilitators as well as the exchanges between participants. To consult the details of the program of a workshop session, simply click on the title and consult the summary :
- Session #1 – 19 nov. from 9:30am to 12:30pm
- Session #2 – 19 nov. from 2:30pm to 5:30pm
- Session #3 – 26 nov. from 9:30am to 12:30pm
- Session #4 – 26 nov. from 2:30pm to 5:30pm
They will carry out the investigation process in the laboratory, taking into account the regulations in force and the European and American guides. Concrete examples may be submitted by participants at the time of registration to be discussed during the workshop. Restitution of the work of each group and handing over of all the supports on 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 anywhere, 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 causes of the deviation in order of course to prevent them effectively 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 new appendix 1
The objective of the workshop is to cover case studies as well as current strategies in the industry for contamination control. The audience will be given case studies and have an opportunity to implement the 5 Whys, risk-based thinking, and fishbone (Ishikawa) diagrams to come up with potential viable root causes. The attendees will also have an opportunity to play a contamination control Jeopardy Game with the winning team being crowned grand champion and the greatest of all time. Attendees will learn about case studies in contamination control, risk-based thinking, the latest global industry regulations impacting contamination control. The attendees will experience hands on exercises at determining the potential root causes in case studies.
-What the attendees will expect to learn and reminding that this is interactive with subgroup activities.
The attendees will experience a hands-on interactive experience with the Jeopardy game and hands on exercise with contamination control case study root cause analysis. The audience will have an interactive environment to share their experiences and knowledge with the workshop class.
- Which profile should attend this workshop?
• Validation Managers
• Quality Control Managers
• Quality Assurance Managers
• Lean Managers
• Operations Managers
• Cleanroom Managers
• Regulatory Affairs Managers
• Production Managers
- Workshop format:
This workshop will include a Jeopardy competition along with an interactive slide presentation and case studies for each group. We will have the following eight categories in the Jeopardy competition related to contamination control: viral safety, cleaning and disinfection, spores, aging facilities, data integrity, environmental monitoring, disinfectant validation, and root causes. There will be ten questions in each category with an answer to each question. There will be more difficult questions in each category with higher point values. At the end of the competition will come a final Jeopardy question where each audience member can decide how many points they wish to wager on the final question. If there is a tie at the end there will be a playoff question. The winner will receive a prize and a certificate for being the overall competition winner. The questions in each category will have a points value and will go from easier questions to more difficult questions at the end of each category. The audience will truly have a very interactive and educational experience and we expect full audience participation. The presenters will work together on designing and developing the content of each question and the answer that most appropriately fits the designed question. We would expect high audience participation and an overall great informative and educational experience. "
It has been 2, 3 years that questions have been asked during the congress on these themes and the answers are not simple. In the last annex 1, there is also the topic concerning the relevance of airborne disinfection versus autoclave sterilization which we will also be addressed.
The idea is to implement a cleaning and disinfection strategy for all surfaces under a filling line of injectables in isolator and RABS.
We will propose practical exercises to deal with the different surfaces involved.
Applicability: Sterile, non-sterile, biotech...
The objective will be to find together the "right" LEAN tools to improve the company's performance !
State of the art in the design of water production/distribution facilities for pharmaceutical use
Regulatory adaptation and change control
Relabelling HPW vs Purified Water/WFI + Monitoring and qualification role
Workshop part : Design of an WFI production/distribution facility incorporating new regulatory trends
You will create a Decision flow diagram for the design of a WFI production/distribution plant
Concrete examples, a water loop, cleaning of a tank, zoning plan etc, will be implemented through this workshop and will serve the explanations given, The objective is to make this workshop interactive with the participants so that it is they who ultimately find the solutions and implement them through the concrete example.
Through this interactive session, we will seek to provide guidance on solving the data integrity problem and demonstrate to our industry that:
• Utilizing an organized, risk-based approach to closing human error gaps in your processes allows to prove that the data used to determine product quality is integral and accurate.
• Examining real-world examples from the industry allows for the evaluation of your own processes for unnecessary data integrity and human error risks.
New technologies play an increasingly important role in reducing a laboratory’s risk to human error and data integrity
1 year after the first edition, take part in this workshop to discover the solutions deployed on industrial sites and work in groups to complete your knowledge. Also, benefit from additional feedback compared to the first edition. Digital , Digital , Digital. This term is heard everywhere, but what is the situation today in pharmaceutical plants? Which solutions are really operational, useful for the teams and for which benefits?
Participants will discover the solutions deployed on industrial sites and will work in groups to complete their knowledge.
3 concrete cases of interest to the industry will be presented:
• Digital and virtual reality training for operators
• Digital solutions for QC labs and how to succeed in their deployments
• Electronic batch record for production
During the morning, as an introduction, the leaders will present an overview 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 from projects carried out by major groups in the pharmaceutical industry with whom Altran was able to work in 2019 and will roll out deployments in 2020.
These feedbacks will therefore be reinforced by the richness of these collaborations both in the initial phases of designing digital solutions, and in their implementation and appropriation by operators.
At the end of the morning and during the afternoon, each participant will join a sub-group:
• Digital training: the group will define approaches and solutions to train operators in Class A/B.
• QC 4.0: the group will share on digital solutions for QC labs, such as LIMS /ELN solutions, augmented reality applications, data management and data analytics,...for QC labs.
• Electronic batch record: the group will work on the preparation of a draft electronic batch record.
The leaders will assist the sub-groups with pedagogical and playful approaches and with their knowledge.
Each group will share the synthesis of its work to all the participants.
This workshop is intended for production, quality, QC, engineering, HR and site managers, who will be able to participate in the sub-group according to their functions and aspirations.
Participants will acquire knowledge that they will be able to put into practice in their companies.
A strong emphasis will be placed on interaction, creativity and sharing among participants.
This strategy will begin with an analysis of the process indicators in their initial state, will continue with a process risk analysis, the definition of a new control strategy, the implementation of regulatory actions (validation, submission) and will end with the implementation of monitoring actions in order to ensure continuous control of the process.
Congrès Annuel A3P
- Session 1/2 day virtual CONFERENCES : 250 € (EXCL. VAT) // Possibility to participate in 1 or more conference sessions (Cf proposed themes)
- Session 1/2 day virtual WORKSHOPS : 250 € (EXCL. VAT) // Possibility to participate in 1 or more workshop sessions (Cf proposed themes)
- Obligation to select at least 1 CONFERENCE session + 1 WORKSHOP session to participate to participate in the A3P 2020 virtual congress
All our webinars are conducted via videoconferencing, which requires a computer with a stable internet connection.
We use TEAMS (Microsoft Office) or ZOOM software to conduct our webinars. These secure and free collaborative platforms allow you to follow and interact with our expert, guests and other participants in the best conditions. These software are compatible with all operating systems (Windows / ios) and offer an online version compatible with many browsers (Internet Explorer, Chrome, Firefox, Safari, etc.).).
The A3P team is at your disposal to accompany you and ensure the proper functioning of your system remotely. To do so, all you need is a computer, ideally with a headset (optional you can use your computer’s micro/audio system) and a stable internet connection.
A few days before the date of the webinar, you will receive an email invitation to access the TEAMS or ZOOM platform. On the “D” day, you will just have to connect via the link. Please make sure to have a quiet and comfortable place to follow this module in the best conditions.
For further information, please contact Natalina SEMEDO :
phone number : +33 (0)4 37 28 30 40
Email : email@example.com
Mail : A3P, 30 rue Pré-Gaudry – Lyon 69007
On site : 30 rue Pré-Gaudry, à Lyon, From Monday to Friday