“Industry 4.0, Smart Factory, Cloud, Digitization, loT, Data Integrity and Compliance for the Life Science industry“
EVENT REGISTRATION
Who is it organized for? The two workshops are aimed at Heads of IT Systems and Architectures, Production Managers, Responsible Machine maintenance, Responsible for IT and OT security and System Integrator who work in the field PHARMACEUTICAL, LIFESCIENCE e F&B.
Why send two distinct figures? IT and OT face different challenges: precisely for this reason ServiTecno and DOTS have decided to carry out this project jointly. There Pharmaceutical House or Machine Builder (or integrator) who would like to be fully trained in optics "opportunity (technological and financial) and methodologies for Industry 4.0″ he can do this by sending one figure per session.
Abstract:
A few years have passed since Marco Annunziata, chief researcher at General Electric, theorized the advent of Industrial Internet. Today in all production companies, even those in the Life Science sector, themes with Cloud, Internet of Things, Smart Factory are on the table of decision makers, and sometimes they are projects launched that are already demonstrating the validity of the choices made and a satisfactory return on investment.
The boost given by the government programs (in Europe and also in Italy) for the digitization of enterprises called Industry 4.0 has provided further vigor to the innovation initiatives already launched or in the evaluation phase.
This Workshop illustrates some conceptual lines and ongoing experiences in the field of Operations, bearing in mind the constraints set by the sector regulation regarding the flow and quality of information in the supply chain, factory organization, preservation and integrity of the collected data and used throughout the production cycle.
The speakers, all recognized experts, will give us their vision and will tell us about how the technologies and system architectures available on the market today, and already used in other different industrial sectors, can now be validly adopted also in the Life Science sector. where we know there are stringent constraints for the regulations in force.
We will also have the testimony of experiences from a Pharmaceutical Manufacturer and a Pharmaceutical Machine Manufacturer, who have already embarked on their Industry 4.0 journey.
Note: This Workshop should be considered combined with the one organized by DOTS entitled "Industry 4.0 when regulatory needs meet technological opportunities" which is held simultaneously in another room, as a sort of separate sessions on different aspects of the same topic “Farma4.0”.
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Workshop Agenda/Schedule
WorkShop coordinator and moderator: Francesco Tieghi, Marketing Mgr, ServiTecno
- 09:00 – 09.15 Registration of participants
- X Welcome, start of work and Introduction to the Theme
Enzo M Tieghi, CEO ServiTecno, Milan
ServiTecno's role as a supplier of technologies and products for factory applications is to propose software and hardware solutions that are the best available today to design and develop systems that can bring returns on investment in a short time, with improvements of efficiency and effectiveness of plants and operators, without forgetting a careful eye on compliance. All this today goes under the umbrella of Industria4.0 and for this sector also Farma4.0
Thirty years of experience that allows us to deal with pharmaceutical companies and machine manufacturers, indicating the steps for innovation and setting the key points with them to obtain reliable and safe applications, compliant with regulations (today also the recent " GAMP Data Integrity Guide”) and increasingly efficient.
- 09:20 - 9:45 Industry 4.0: the key role of vertical and horizontal integration
Teresa Minero, CEO LifeBee, Milan
The new paradigms of Industry 4.0 will be all the more successful the more they are grafted onto organizations that continuously seek excellence in their processes and that have developed an authentic propensity for change. A key role will certainly be played by the ability to sustainably integrate already available applications and technologies (BA, MES/EBRS, LIMS, QMS, CMMS, SCADA and automation) and emerging ones (IoT, Cloud, augmented reality, collaborative robots , etc.) to make operational support more effective, efficient and in line with regulatory requirements and to increase the decision-making capacity of company managers on a predictive basis. The harmonization and integration of processes, systems and procedures will also allow for full "Data Integrity by Design".
To bring the results that we all expect, however, integration will have to cross the entire Supply Chain horizontally (suppliers, production, customers) and the entire company vertically (machines, lines, plants, sites, corporate and regulatory authorities ).
A challenge to be played towards 4.0, but to be played fully.
- 09:45 - 10:15 Industry 4.0 and Data Integrity for Pharmaceutical Industries: Threat or Opportunity?
Pier Luigi Agazzi, Adeodata, Lomazzo (CO)
Starting from the regulatory requirements focused on "Data Integity", i.e. the ALCOA attributes, the requirements for data in electronic format are highlighted: access management, Audit Trail, data backup, data management and of the time, the independence of the directors. All these requirements must also be subject to periodic validation and verification.
The requirements for the outsourcing of IT services in a regulated environment are also focused.
But investments to ensure compliance with Data Integrity requirements, in addition to increasing compliance with regulatory requirements, can become an opportunity to rethink organizational processes, improving business efficiency through the dematerialization (paperless) of documents.
Furthermore, the collection of data in compliance with Data Integrity attributes value to our activities because it helps to better understand what we do and therefore it is an opportunity to improve the way we do it.
Otherwise Data Integrity will constitute just the umpteenth threat that will only contribute to distance us from the organizational models of the most advanced states.
- 10:15 - 10:45 Industry4.0: from the Internet of Everything to the Internet of Ecosystems
Franco Petrucci, Founder and CTO of Decisyon Inc., San Francisco. (USA)
In large organizations, in recent years, a spiral of disillusionment has invested the world of ERP and enterprise information systems in general. The promise of business process integration and the connected organization has never come true, except in part.
These "islands of organization", even if internally connected, have remained fundamentally disconnected from the other business processes and therefore badly integrated with the rest of the organization.
This vertical, siled paradigm has permeated modern organizations for a long time and has meant that, instead of getting connected entities and thus enabling the connected organization, it has not been possible to go beyond entities composed of many different parts unable to integrate and coordinate effectively with each other.
- 10: 45 - 11.00 Application examples of Industry 4.0 and Smart Factory in Pharma
testimonial of a leading pharmaceutical company (invited speaker)
Speech by an Operation Manager of a leading Pharmaceutical Company in which the paradigms of Industry 4.0 will be addressed and above all how hyperconnectivity and ever higher performance from the point of view of sampling, historicization and data analysis can improve the plant efficiency by increasing quality and compliance. Furthermore, the Industry4.0 model will have an impact not only on Life Science Manufacturers, but also on the patients-consumers of the products themselves: what are Companies doing to improve the experience of their Customers-Patients?
- 11: 00 - 11.15 Application examples of Industry 4.0 and Smart Factory in Pharma
testimonial of a leading company, manufacturer of pharmaceutical plants and machines
Franco Gianvanni – Product & Proposal Mng – Advanced Technologies Stevanato Group Engineering Systems
The intervention will concern the analysis of three cases in which Stevanato Group Engineering Systems has implemented Industria4.0 concepts in Pharma:
- Line for clinical trials: single line for the packaging of filled syringes, carpules and vials, packed in 150 different product configurations, with virtually no format change.
- Multiformat line for ready-to-use containers: line for washing and packaging in a sterile area of multiple formats of primary glass containers, many of which an absolute first for the market.
- Intralogistic transport system: automated system for the transport of semi-finished products between the phases of the production process, carried out via rover and managed by a supervisor interconnected with the customer's management lines and software. This case was also illustrated at the recent ISPE workshop in Bologna on Industry4.0
- 11:15 - 11:45 The Augmented Operator in the digitized factory
Bernard Cubizolles, Senior Global Marketing Manager, GE Digital, Paris (F)
The main purpose of an operator screen is to help quickly identify problems and causes: the HMI is the link between the operator and the industrial process. However, many users underestimate the importance of a good design. Operators should be able to recognize which information needs their attention and what it indicates—at a glance. For that, the operator not only needs a good user interface but a system, which delivers a great User Experience. Operator screens are often designed by engineers who turn technical diagrams into plant mimics. They are trying to push the systems to the limits using a profusion of symbols and widgets, too many colors, no hierarchy of information, resulting in an unreadable—more concerning—pretty much useless interface in case of emergency. It translates into increased response time, prolonged downtime and possibly safety issues. At GE Digital, we have worked with selected customers and institutions such as universities in seven different countries to identify the main tools that should be considered when designing an HMI screen. We have come up with nine main topics, such as visual coding, information layout, screen hierarchy and navigation, alarm presentation, and more. These are the rules that we apply when we design our own systems. Adding Augmented Reality to this User Experience we might reach the “Augmented Operator”.
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Speakers:
- Enzo Maria Tieghi – CEO of ServiTecno
Enzo Maria Tieghi, entrepreneur, computer scientist, from Milan, for over 30 years has been involved in software for the automation and control of plants, security and compliance with standards and regulations in various industrial sectors in which ServiTecno is active, a company of which he is CEO. ServiTecno, a company founded in 1979, has been distributing and supporting software and systems for industrial applications for process control, factory automation, plant supervision and infrastructure monitoring since 1985. Active in industry associations (such as AIIC, Clusit, ISPE, Anipla, ISA, AFI, etc.), he holds lectures and participates as a speaker in specialist events both in Italy and abroad, as well as contributing articles and memoirs to specialized magazines and international conferences.
- Teresa Minero – Founder and CEO of LifeBee
Consulting and Digitization dedicated since 2004 to the Life Science sector. More than 30 years of experience in the management of Consulting and Digitization projects for Production, Logistics, Quality, Regulatory and R&D; the last 25 years have been spent exclusively in life sciences. You are also the President of the Italian Affiliate and "European Affiliate Council" Vice Chair of ISPE, the largest worldwide non-profit association for Life Science professionals.
- Pier Luigi Agazzi – Adeodata
Graduated in electronic engineering in 1985 at the Milan Polytechnic, he attended the MIP evening master "Technological choices and business management" at the Milan Polytechnic and deepened his studies on expert systems for process control at MIT in Boston, USA.
In the period 1985/89 he was involved in the design of process control systems in the SNIA group also as head of the process automation and instrumentation department, collaborating in particular on some European research projects (ESPRIT).
From 1993 to 1999 he worked in STERIL as head of the automation and instrumentation department and as coordinator of the validation activities of the automated systems, participating in the design and construction of various highly automated pharmaceutical plants.
Since 2000, as a consultant at Adeodata, he has been involved in the validation of IT and automated systems, also carrying out Audits, compliance checks with Annex 11 and 21CFR Part 11, Data Integrity and training courses in collaboration with Quality Systems.
He is currently involved in international project teams in Italy and abroad.
Active member of the IT group of AFI since 1993 and of ISPE since 1994. He has also actively cooperated in the activities of the European Batch Forum and AIS (Italian Association of Toolmakers).
- Franco Petrucci – Founder and CTO of Decisyon Inc.
Advisor, Manager raised in the ICT world with experience in IT services, Supply Chain, Pharma, Financial Services; CEO of some ICT companies in Italy and abroad; Founder, Board Member and CTO of Decisyon startup founded in Italy and leader in unified technologies for the Internet of Everything, today an American company thanks to venture capital investments of over $50m ( www.decisyon.com ).
- Franco Giovanni
Product & Proposal Mng – Advanced Technologies Stevanato Group Engineering Systems
After graduating in Electronic Engineering from the University of Pisa and starting his career in the automotive sector, with experiences in GM-Fiat and Pininfarina, Franco Gianvanni continued in pharmaceutical packaging, first following Procurement for Ompi and then as Supply Chain Manager . Wanting to acquire a complete corporate vision, he dedicated himself to Project Management of strategic projects, which led him to become responsible for the most innovative product lines of the Engineering division of Stevanato Group.
He is currently responsible for growing the new business unit dedicated to "Industy4.0" projects.
- Bernard Cubizolles – Senior Global Marketing Manager at GE Digital
Bernard Cubizolles is the global product marketing manager for GE Digital. He has been with General Electric for over 10 years and holds a PhD in applied physics. In his 20-plus-year career, he has become a recognized expert in the process industry. His expertise in industrial automation helps companies achieve real value from the Industrial Internet. By using software and mobile solutions, Bernard believes infrastructure and manufacturing executives can transform big data into actionable information and knowledge.