Programme

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Technical PresentationLive-streamed education sessions.

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Day 1
Mon, 11 Dec
  • 0730 - 1830
    Registration Open
    Registration open: Monday, 11 December 0730-1830 CET. 

    Registration will also be open on Sunday, 10 December from 1300-1700 CET.
  • 0900 - 0920
    Welcome to the 2023 ISPE Pharma 4.0™ and Annex 1 Conference
    Speakers

    Thomas B. Hartman
    President and CEO
    ISPE
  • 0920 - 0950
    Welcome Address
    Speakers

    Maria Jesus Lamas Diaz
    Director
    AEMPS (Spanish Agency of Medicines and Healthcare Products)
  • 0950 - 1020
    Advancing Digitalisation in Manufacturing - EU Initiatives
    The digital revolution in medicine manufacturing offers opportunities for better understanding and control of the manufacturing processes and therefore better quality of medicines for patients and faster scale up/out with positive impact on medicine availability. The presentation will provide an overview of EU Regulators’ initiatives to support the rapid growth of advance manufacturing technologies. It will present the role of the Quality Innovation Group (QIG), activities at international level aiming towards convergence as well as some key learnings from the QIG Listen and Learn Focus Group meeting on digital tools in manufacturing and control.
    Speakers

    Evdokia Korakianiti
    Head of Quality and Safety of Medicines
    EMA
  • 1020 - 1050
    Quality Thinking in Lightspeed – People Making a Pandemic Vaccine
    In this presentation, following elements will be discussed: What´s different during a Pandemic; How we changed the thinking, talking, taking actions and the affect on culture; How we simplified things; Learnings (for the future)
    Speakers

    Christoph Prinz
    Vice President Global Operational Quality
    BioNTech
  • 1050 - 1100
    ISPE Foundation
    Speakers

    Teresa Minero
    Founder & CEO
    LifeBee - Digitalizing Life Sciences
  • 1100 - 1130
    Networking Break in the Exhibition Area
  • 1130 - 1215
    Regulatory Panel Discussion: Practical Applications of Current Standards and Regulations in the Context of Digitalization
    The Pharma 4.0™ and Annex 1 Regulatory Panel Discussion will bring together regulators from around the world to provide insights on the implementation of Pharma 4.0 concepts to different manufacturing technologies. Panelists will discuss the interpretation and practical application of current standards and regulations in the context of digitalization, and outline opportunities for future harmonization that can facilitate digital transformation including technologies such as the use of Artificial Intelligence.

    This year you will have a unique opportunity to participate and have your questions answered: SUBMIT NOW  (deadline 4 December)
    Session Leaders

    David Churchward
    Global Head Sterility Assurance, Cell and Gene Technologies
    Lonza Biologics

    Yvonne Duckworth, PE
    Fellow - Digital Technology, Associate
    CRB
    Speakers

    Joel Welch, PhD
    Associate Director for Science, Office of Biotechnology Products (OBP)
    FDA

    Manuel Ibarra Lorente
    Head of Pharmaceutical Inspection & Enforcement Department
    AEMPS (Spanish Agency of Medicines and Healthcare Products)

    Evdokia Korakianiti
    Head of Quality and Safety of Medicines
    EMA
  • 1215 - 1235
    Digital Transformation Journey: Insights from the Pharma 4.0 Baseline Guide
    The digital transformational journey started in ISPE with an initiative called “Pharma 4.0” already in 2017 based on the industry 4.0 digitalization technologies, methodologies and digital maturity assessment principles, taking the Pharma specifics like regulatory requirements in the focus. Starting as an ISPE Special Interest Group, the today's ISPE “Pharma 4.0” Community of Practice / CoP created a holistic Baseline Guide, which as a repository is arching from the how to convince management to start the holistic digital transformational journey, the technology enablers up to the first use cases showing the benefits and challenges in the implementation. The transformational challenges and critical success factors gathered by more than 30 authors of the chapters and use cases in creating this guide for your digitalization journey will be shared and help you to manage your digitalization travel plans!
    Speakers

    Christian Wölbeling
    Executive Industry Advisor
    Körber Pharma Software GmbH
  • 1235 - 1250
    7th Annual ISPE Pharma 4.0™ Survey - Application in Industry
    Speakers

    Teresa Minero
    Founder & CEO
    LifeBee - Digitalizing Life Sciences
  • 1250 - 1300
    Message From Conference Chairs
    Message from Conference Chairs
    Speakers

    Cristina Mazó
    Site Manager
    ISPE Iberia Affiliate

    Jörg Zimmermann
    Vice President Vetter Development Service External Affairs
    Vetter Pharma Fertigung GmbH & Co KG
  • 1300 - 1400
    Networking Lunch in the Exhibition Area
  • 1400 - 1430
    Air Speed at Working Position. At Working Level?
    The new EU GMP Annex 1 “Manufacture of Sterile Medicinal Products” in its final version published on August 25th 2022 requires in paragraph 4.30 “…a homogeneous air speed in a range of 0.36 – 0.54 m/s (guidance value) at the working position…” WHO in January 2023 published their Annex 2 “WHO good manufacturing practices for sterile pharmaceutical products“ and provided a different wording: “…a homogeneous air speed in a range of 0.36–0.54 meters per second (m/s) (guidance value) at the working level…“ This raises the question of “Where to provide which air speed and where to measure and monitor the air velocity?” This presentation initiated by the steering committee of ISPE D/A/CH Community of Practice “Aseptic Processing” wants to show with real data the effect on unidirectional airflow pattern and air velocities at point of fill: working position as well as working level. The data were generated based on CFD simulation with a machine model (vial filling/closing machine) in an open double wall isolator environment. Additionally air velocity measurements and airflow visualization studies were performed with the real model – machine (detailed mock-up) inside real isolator.
    Speakers

    Johannes M. Rauschnabel, PhD
    Director Advanced Technology Development and Innovation
    Syntegon Technology GmbH
  • 1400 - 1430
    Advancing Pharmaceutical Quality: The Knowledge Enabled Organization
     Companies are seeking to digitize, digitalize, and transform their business processes and organizations.  Now more than ever, organizations must seek boundaryless data, information and knowledge flow to ensure their colleagues have the knowledge they need to make timely and informed decisions. Linking with the ICH Q10 enabler of Knowledge Management, this session will holistically:   1)Share the concepts of knowledge management to enable knowledge flow  2)Offer how organizations may think differently about ways of working, new roles, and organizational constructs in a digitalized world to enable information and knowledge flow.  Note this will be further discussed in the Fireside chat with Teresa Minero and Heike Roeder in the following talk.  3)Considerations for digitizing and improving processes, within the PQS and the business; how we might capture and harness the ‘know how’ from our people in our processes?
    Speakers

    Paige E. Kane, PhD, CPIP
    Director Knowledge Management
    MSD
  • 1430 - 1500
    Validation and Qualification Approach in New Annex 1
    The updated version of Annex 1 further emphasizes validation and qualification in a holistic approach, harmonized with an integrated implementation plan that has its foundation on a partnership between all pharmaceutical departments. Each pharmaceutical process and its respective validation or qualification demonstrate how implementation and adherence to intended purpose need to take into consideration all the product characteristics that have an impact on quality. Minimizing the risk of microbial, particulate, and endotoxin/pyrogen contamination is essential when producing sterile products. These characteristics ought to be studied, controlled, and included in the definition of a control strategy. Several types of sampling tools can be applied to meet these environmental monitoring requirements. Active air sampling is regarded as the most interesting way to collect repeatable samples, possibly with automation, and a single use device could facilitate sample integrity in routine usage. The main driver is always the understanding of the process and a higher predictability of outcomes, which sometimes means faster decision-making paths in case of excursions. A complete qualification is very important for the entire validation process both in terms of accountability and reproducibility from a quality point of view. A deep understanding of your process means that the materials brought in will likely produce a usable and sellable product, limiting the risk of shortages, reducing rejections, and subsequently lowering costs.
    Speakers

    Serena Steidl
    Advisory Specialist
    Particle Measuring Systems
  • 1430 - 1500
    Organizational Development as Priority for Successful Digital Transformation - Fireside Chat
    After years of digital transformation with focus on investment into new technologies, data, systems the life sciences industry have identified organization development as the challenge. However, the typical change management campaigns like communication, upscaling digital skills, and hiring data scientists are not enough. Teresa Minero and Heike Roeder both experienced digitalization transformation leader will interactively discuss the following aspects: - Illustrate the dimension of the transformational journey going through the digital maturity as fundamental new organizational set-up and leadership - Provide insights of industry feedback together with real life experiences, and their specific challenges - Envision and share the principles for a successful organizational development as holistic transformation
    Speakers

    Heike Roeder
    Vice President QA International
    Cencora

    Teresa Minero
    Founder & CEO
    LifeBee - Digitalizing Life Sciences
  • 1500 - 1530
    End-to-End CCS in ATMP Through Advanced Risk Profiling
    The quality of the CCS is highly dependent on the resolution of the available risk data - the more accurate this risk data is, the more targeted and effective these control mechanisms can be. The presentation introduces the Frame-by-Frame Risk Profiling approach for generating end-to-end CCS. Frame-by-Frame Risk Profiling identifies trends and recurrent patterns that indicate potential risks to the process. Process-frames have resulted from contextual and operational aspect assessment of the task and the context in which the process occurs. Accumulation of these process-frames have led to data-based frame library that provides a centralized repository of information that can benefit to inform the assessment process consistently and objectively. Every process-frames incorporate high-resolution risk data which can be used to generate end-to-end CCS for ATMPs. By linking to the Process Frame Library, an end-to-end CCS can incorporate targeted risk mitigation strategies for MBR, work instructions, QA monitoring guidelines, and training, and keep all information consistent across processes and manufacturing sites. Furthermore, end-to-end CCS incorporates Pharma 4.0 technologies such as Virtual Reality in order to train and assess operator behavior. The presentation will also share insights from implementation of Frame-by-Frame Risk Profiling Pilot at Johnson & Johnson CAR-T.
    Speakers

    Sebastian Scheler
    Managing Director
    Innerspace GmbH
  • 1500 - 1530
    Advanced Data-Driven Process Performance and Product Quality Monitoring System (PPPQMS) for Real Time Quality Decisions
    Pharmaceutical Product Quality is the outcome of enhanced process understanding combined with decisions made based on process and product data. In this session I will discuss how the pharmaceutical quality can be enhanced by having access to the right data at the right point in time, making it possible to make real time quality decisions. Being able to make such decisions requires an improved Process Performance and Product Quality Monitoring System (PPPQMS) by acknowledging the digital opportunities that we have. In order to express an enhanced process understanding in a Holistic Control Strategy and to be able to make real-time quality decisions, we must have access to real-time process and product data; have systems connected across the manufacturing supply network; and have defined supportive analytical and continual improvement elements. The ISPE APQ PPPQMS guide has been developed to support the industry in establishing a PPPQMS system with its different elements for Quality 4.0. At this session I will provide practical examples of the elements of this system.
    Speakers

    Line Lundsberg-Nielsen, PhD
    Managing Consultant, Compliance Consulting
    NNE
  • 1530 - 1600
    Networking Break in the Exhibition Area
  • 1600 - 1630
    Case Study on Implementation of a Contamination Control Strategy
    Speakers

    Cathrine Friberg
    Specialist, Manufacturing Development
    Novo Nordisk
  • 1600 - 1630
    Navigating Quality Maturity and Digital Transformation to Create a Culture Beyond Compliance
    At the forefront of progressive enterprises, there is a continuous and concerted effort to foster a culture where the responsibility for quality practices and results is shared across functions. This entails not only the evolution of robust quality practices and competencies but also the serious endeavor to ingrain every function of the organization with a prevalent culture of quality. The overarching objective here is to cultivate a landscape where ownership and active participation in all aspects of operations converge to yield outcomes of the highest quality.  In this presentation, we will discuss the pivotal role of quality culture in shaping quality maturity. Furthermore, we will elaborate on the six sub-elements of ISPE APQ cultural excellence: 1) leadership and vision, 2) mindsets and attitudes, 3) Gemba and employee engagement, 4) leading quality indicators, 5) proactive oversight, and 6) quality enablers and we will elucidate their intricate connections with systems, data, processes, and the organizational framework. Finally, our focus will shift to the implementation of digital strategies that support quality maturity and increases manufacturing efficiency and productivity while nurturing a culture of quality that effectively addresses both compliance requirements and competitive advantage.
    Speakers

    Maria Amaya
    Lead External Advocacy North America (Quality Policy)
    Genentech, A Member of the Roche Group
  • 1630 - 1700
    Implementation of Contamination Control Strategy
    Speakers
    Placeholder Person Graphic

    Paul Sebastien Fiorio
    Bayer Consumer AG Pharmaceuticals Cell and Gene Therapy
  • 1630 - 1700
    Application, Validation and Verification of End-to-End Process Digital Twins
     End-to-end models enable risk informed predictions of final product quality as a function of any process parameter (PP) of individual unit operations. This is where the resulting quality can be directly compared to drugs substance/ drug product specifications, relevant for patient safety and efficacy. This is beneficial over the use of process models from individual unit operations as they only predict intermediate quality and do not allow for assessing final product quality.  When it comes to verification and validation, a central approach to rate applicability and credibility of models within the V&V40 framework is to compare the model including its uncertainty to acceptance limits. The presentation will show how end-to-end process models can (1) correctly account for sources of variability in uncertainty quantification and (2) how to overcome the necessity to define acceptance limits for intermediate process steps.
    Speakers

    Thomas Zahel, PhD
    Head of Innovation
    Körber Pharma Austria GmbH
  • 1700 - 1730
    Panel Discussion With Speakers From Track 1
    Speakers

    Sebastian Scheler
    Managing Director
    Innerspace GmbH
    Placeholder Person Graphic

    Paul Sebastien Fiorio
    Bayer Consumer AG Pharmaceuticals Cell and Gene Therapy

    Serena Steidl
    Advisory Specialist
    Particle Measuring Systems

    Cathrine Friberg
    Specialist, Manufacturing Development
    Novo Nordisk

    Johannes M. Rauschnabel, PhD
    Director Advanced Technology Development and Innovation
    Syntegon Technology GmbH
  • 1700 - 1730
    Next Gen Pharma Quality Management: Unleashing the Power of a Modular Approach
     This presentation will delve into the concept of a modular approach to pharma quality management, breaking it down into smaller, more manageable components such as Business Process Management, Documents & Records Management, GRC, and Regulatory Management. By examining each component in detail, we will understand how their integration can revolutionize quality management practices within the pharmaceutical industry. We will highlight the advantages of adopting this modular approach, such as improved efficiency, enhanced process control with fully automated processes, and reduced costs. Additionally, we will delve into the transformative potential of data analytics and data visualization in identifying trends, risks, and areas for improvement within the quality management system.
    Speakers

    Jeremie Arrault
    Head of QMS
    Galapagos NV

    Mirco Thomas
    Managing Director
    Interfacing GmbH
  • 1730 - 1930
    Welcome Reception in the Exhibition Area
Day 2
Tue, 12 Dec
  • 0730 - 1800
    Registration Open
  • 0815 - 0915
    Leadership Agility: Adapting to the Evolving Landscape of the Industry - Powered and led by ISPE Women in Pharma®
    Join an insightful panel discussion powered and led by ISPE’s Women in Pharma on "Leadership Agility: Adapting to the Evolving Landscape of the Pharmaceutical Industry. Throughout this hour-long discussion, seasoned leaders from diverse backgrounds come together to share their perspectives on navigating the rapidly changing landscape of the pharmaceutical industry. In an era marked by digital advancements, economic uncertainties, and unprecedented global challenges, the need for leaders to adapt and respond with agility has never been more crucial.  

    Our panelists, each with a wealth of experience in their respective fields, will delve into the key aspects of leadership agility, exploring how leaders can effectively steer their teams and organizations through constant change. From embracing innovation and fostering a culture of adaptability to making informed decisions amidst ambiguity, our panelists will offer valuable insights drawn from their own leadership journeys.

    Topics to be covered include:

    Adapting to Change: How do successful leaders navigate and embrace change, fostering a culture of agility within their teams?

    Innovation and Creativity: Discussing the role of leaders in promoting a culture of innovation, and how agility contributes to staying ahead in competitive markets.  

    Decision-Making in Uncertainty: Exploring strategies employed by agile leaders to make informed decisions in situations of ambiguity and unpredictability.

    Continuous Learning: Highlighting the importance of continuous learning for leaders and organizations, and how it contributes to innovation.

    Building Resilience: Examining how resilient leadership plays a crucial role in overcoming challenges and setbacks, fostering long-term organizational sustainability.  

    Our panelists will share personal anecdotes, practical tips, technological resources, and lessons learned, providing the audience with actionable insights to enhance their own leadership agility.
    Session Leaders

    Yara Ahmad Almouti, Sr.
    CEO and Projects Director
    Agon for Training and Consulting
    Speakers

    Vivianne J. Arencibia
    Vice President, Global Quality Systems and Compliance
    Moderna
    Placeholder Person Graphic

    Vanda Vieira Vicente
    Project Manager
    Insud Pharma

    Yvonne Duckworth, PE
    Fellow - Digital Technology, Associate
    CRB

    Teresa Minero
    Founder & CEO
    LifeBee - Digitalizing Life Sciences
  • 0930 - 1000
    Integrating a Prefilled Syringe Filling Line into a Legacy Facility
      Integration of a PFS & DA technology platform into an operating legacy facility, considering Annex 1 and Production 4.0. How to engage quality topics, as well as cost containment, in a routine production with limited information about product development, challenging deadlines and complexity deriving from Cold Chain processing of aseptic prefilled syringes and assembly within an autoinjector. Product is to be produced in high amounts, thus automation is key for success. This experience comes from a real project currently implemented in a site which is 25 years old, leveraging existing installations and upgrading those areas which are not yet suited for new processes.
    Speakers

    Sergi Solano
    Engineering Manager
    Boehringer Ingelheim
  • 0930 - 1000
    Delivering a GPG for Container Traceability in 2024
    Modern parenteral manufacturing operations are driving the need for greater precision and visibility in each process to supplement traditional control strategies. These data-based decisions can reduce risk, accelerate drug delivery, and improve patient safety. The ISPE have established a working group under the umbrella of the SCOPE Community of Practice. The group comprises of sixty-seven [67] stakeholders across the industry who account for around 80% of the manufacturing capacity. The aim is to publish a Guidance Document in Q1 2024 which is designed to support pharmaceutical manufacturers with the implementation of unique containers in their manufacturing operations. This presentation will cover a range of topics across the pharmaceutical supply chain, illustrated with uses cases and key learnings. It will demonstrate why container traceability is crucial for process optimisation success and to maximise the original return on investment?
    Speakers

    Robert Tod Urquhart
    Executive Industry Adviser
    CIM A/S
  • 1000 - 1030
    APS: Risk Based, Compliant & Cost Effective Approach
    Problem: APS is a hot topic & area of focus of USFDA & EU regulatory inspections. It costs a lot when not in compliance (warning letters, patient safety) and also when overdesigned without applying risk based approach. Target: After Annex 1 updates with more details, introduction of CCS concept and more focus on quality risk management, To design APS that is satisfying all regulatory requirements in a cost effective risk based way. Proposal: 1- Rapid review of APS & its importance. 2- Where in Annex 1 APS was mentioned? 3- Relationship between APS, CCS & QRM. AS0 is a part of CCS (validation & monitoring). QRM is essential for developing CCS & APS design; however priority should be given to design controls, followed by procedural controls and finally to monitoring systems. 4- How to use QRM in APS to focus resources on real risks. 5- Practical examples of cost effective risk approach to APS. 5 1. How to simulate different dosage forms on same line with minimum no. of runs. 5.2 How to use risk assessment to define a risk based frequency for intervention simulation. 5.3. How to use QRM to simulate all container sizes with minimum no. of runs.
    Speakers

    Morcos M. Loka
    Quality Senior Manager Biologics F&F and New Projects
    Minapharm
  • 1000 - 1030
    Predictive Inventory in Supply Chain Analytics
    The presentation details Merck's approach to address the common challenge of supply chain resilience. By enhancing our ability to forecast demand, optimize inventory levels, and proactively respond to disruptions, we aim to build a resilient supply chain that drives customer satisfaction and sustains our competitive advantage. This strategic undertaking reinforces our commitment to operational excellence and supply chain resilience. Specifically, we are targeting resilience through “Predictive Inventory Management”, which is crucial for balancing customer satisfaction and cost optimization. During the presentation, I want to take the audience on our journey of Supply Chain Analytics: Starting with the definition of “future” analytical capabilities, exploring use cases and the challenge of “just” getting started in this complex environment. During this journey, it is crucial for us to identify success factors we need to build and encourage as an organization – including technologies, people’s skills- and mindsets.
    Speakers

    Katja Hoppmann
    Senior Project Manager Smart Manufacturing
    Merck KGaA
  • 1030 - 1100
    Impact of Annex 1 on Blow-Fill-Seal Technology
    The Annex 1 2022 has an impact on existing BFS systems and will influence the development of new BFS systems. The presentation will show how existing BFS installations could be implemented in the Contamination Control Strategy. Additionally, the presentation covers how new Annex 1 compliant BFS installation look like and what can be expected for new installations and future developments. It will be explained that regulatory compliance, sustainability and cost-effectiveness can be complementary and not contradictory. - The changes for BFS-Technology between the Annex 1 2008 and Annex 1 2022 will be elaborated - With examples it will be demonstrated, what has to be done for running BFS-Systems to fulfill Annex 1. - The differences between the important new differentiation in the Annex 1 between open parison technology and closed parision technology will be explained. - On a practical example it will be shown how to implement a Contamination Control Strategy for BFS-Technology - New developments in BFS-Technology will be presented for new BFS-Technology to fulfill the Annex 1. - The actual literature will be delivered, to get an overview and to find further information.
    Speakers

    Christoph Bohn
    Director
    Rommelag Pharma Service

    Thomas Obenauer
    Product Manager
    Rommelag AG
  • 1030 - 1100
    Applying Pharma 4.0 to Expand Access to Biotherapeutics
    Fewer than 10% of the world's population has access to biopharmaceutical therapeutics for treating chronic and life-threatening conditions as well as infectious diseases. Barriers to access include the high cost of biopharmaceuticals for payers and patients, long lead times for the development of biopharmaceutical drugs and limited access to biopharmaceutical manufacturing capacity in mid-and low-income countries. This inequity of access demands that the pharmaceutical industry apply innovative solutions that leverage Pharma 4.0 principles to develop and implement solutions to significantly reduce the cost of goods (CoGs), accelerate product development timelines and develop a distributed network of highly efficient biopharmaceutical manufacturing facilities.
    Speakers

    Charlie Maher, BS, MBA
    VP Manufacturing & Site Head
    Just-Evotec
  • 1100 - 1130
    Networking Break in the Exhibition Area
  • 1130 - 1200
    GAP Assessment Strategy for the New Annex 1
    This presentation will be focusing on the assessment strategy for the review and implementation of the new requirements of EU- GMP Annex 1. It will be based on the experiences of Boehringer-Ingelheim GAP assessment strategy, as a practical approach, considering how to address changes in current regulation as a multidisciplinary task, involving all areas with impact in the manufacturing of sterile products and how it has been addressed for new facilities and existing legacy facilities. It will also include GAPs evaluation, classification strategy and remediation activities and how their implementation has been addressed. For a better understanding of the new requirements of EU- GMP Annex 1 and in order to align its implementation, the GAP assessment has been addressed at a global level for all Boehringer-Ingelheim sites impacted.
    Speakers

    David Alonso
    Sterility Assurance Technician
    Boehringer Ingelheim
  • 1130 - 1200
    Roadmap to Deliver Real Value from Pharma 4.0
    The biopharma manufacturing industry has been on the journey to transform Manufacturing plants around the world into advanced Pharma 4.0 Smart Factories. Based on his extensive experience Simon will share reflections on the journey so far, key approaches, risks and lessons learnt, which have together have resulted in real tangible value delivery for productivity, sustainability, patients, and the workforce.
    As part of this he will share how factories are being ‘re-plumbed’ for on-demand data, together with specific example use cases which are delivering transformational value. He will also discuss how new factory investments now need to be designed with a digital-first approach where the 'data and digital' are just as important are the 'concrete and stainless steel'.
    Speakers

    Simon Webb
    Founder & CEO
    Liminos
  • 1200 - 1230
    Automation of Formats Loading Line for GMP Freeze Dryers
    This lecture addresses the issues in setting-up an automatic line to load and unload GMP freeze dryers with multiple formats under isolation technology, as well as the procedures to introduce multiple formats, cleaning, sanitisation, and line clearance. It also analyzes pros and cons of having multiple formats ready to use inside the isolator versus the introduction of formats at the time of use, in addition of risks of contamination. Is it possible to replace the manual formats by a fully automatic device that adapts to multiple formats? What are the limitations? What are the process validation implications? How production and maintenance procedures change? ROI implications, CAPEX versus OPEX.
    Speakers

    Xavier Gomez
    Lyophilization Product Manager
    Telstar
  • 1200 - 1230
    Digital-Engineering to Operations-Realization Insights
    Several, often interlinked trends are currently the driving change in the pharmaceutical industry and placing unprecedented demands on agility, flexibility and adaptability. To achieve the expected profit, production of a new drug should start immediately after its approval. However, the planning and construction of the required plant is started at the latest possible stage. In addition to ever faster time to market, increasing competitive pressure is forcing pharmaceutical manufacturers to be best-in-class. At the same time, it is imperative to work with maximum cost efficiency. During operation, several digital solutions provide support for daily tasks: digital/electronic qualification and validation, virtual & augmented reality for training & support, smart maintenance or monitoring and diagnosis applications are some examples. These solutions combine meta data (e.g: article numbers, location, spare part number, 3D model etc.) with real-time data and the effort to acquiring the meta data is significant. Most of these meta data is essential during the engineering phase and by integrated, digital engineering this data is made available in a smart way. We will present the benefits on two realized 100+ Mio project (Boehringer, Vienna, LOBA GmbH)
    Speakers

    Martin Mayer
    Director Business Line Digital Solutions
    ZETA GmbH
  • 1230 - 1300
    Panel Discussion with Speakers from Track 3
    Speakers

    Christoph Bohn
    Director
    Rommelag Pharma Service

    Thomas Obenauer
    Product Manager
    Rommelag AG

    Sergi Solano
    Engineering Manager
    Boehringer Ingelheim

    David Alonso
    Sterility Assurance Technician
    Boehringer Ingelheim

    Xavier Gomez
    Lyophilization Product Manager
    Telstar

    Morcos M. Loka
    Quality Senior Manager Biologics F&F and New Projects
    Minapharm
  • 1230 - 1300
    Panel Discussion With Speakers From Track 4
    Speakers

    Charlie Maher, BS, MBA
    VP Manufacturing & Site Head
    Just-Evotec

    Simon Webb
    Founder & CEO
    Liminos

    Robert Tod Urquhart
    Executive Industry Adviser
    CIM A/S

    Martin Mayer
    Director Business Line Digital Solutions
    ZETA GmbH

    Katja Hoppmann
    Senior Project Manager Smart Manufacturing
    Merck KGaA
  • 1300 - 1400
    Networking Lunch in the Exhibition Area
  • 1400 - 1430
    Annex 1 Aseptic Powder Filling Challenges
    Speakers

    Ricardo Grilo
    Operations Director
    Laboratórios Atral S.A.
  • 1400 - 1430
    Analysis of 30+ Pharma 4.0 Use Cases - Enabling Technologies, Benefits, Challenges and Lessons Learned 
    We'll share an “high level summa” of 30+ Pharma 4.0™ Life Sciences End User Case Studies that have been collected while in the process of writing the ISPE Baseline Guide dedicated to Pharma 4.0™ (whose publication is scheduled for the end of 2023) highlighting the problem statement, the solution, the mix of enabling technologies, the involved departments, the benefits, the challenges and the lesson learned. The uses cases are based on the following enabling technologies: GxP Cloud, Smart and Wearable Devices, Collaboration Platforms, Big Data and Advanced Analytics, Industrial Internet of Things (IIoT) , Artificial Intelligence/Machine Learning (AI/ML), Process Mining, Natural Language Processing, Image Recognition, Advanced Modeling , Advanced Robotics, Augmented Reality (AR), Virtual Reality (VR), Additive Manufacturing, Robotic Process Automation (RPA), Blockchain, Speech and Gesture Recognition, Edge Computing".
    Speakers

    Edoardo Schiraldi
    Corporate Program Manager
    Menarini
  • 1430 - 1500
    A USA Perspective of the Regulatory Landscape
    Speakers

    Ryan W. Waldhart
    Senior Manager of Manufacturing Science & Technology
    Grand River Aseptic Mfg Inc
  • 1430 - 1500
    Improving Aseptic Interventions with AI-supported Monitoring – Review of a Pilot in a GMP Production
    AI-assisted detection and classification of human intervention into the aseptic core has now reached a level of maturity that allows the system to be validated and thus be used in a critical GMP area. Nevertheless, introducing an AI system in routine production raises questions not only from quality assurance and authorities but also from many other parties including managers, operators and workers council. In addition, various aspects of the project were scientifically accompanied in order to research effects on the working environment in a highly related and risky environment in general and the cleanroom behavior of operators in particular.
    Speakers

    Christoph Koeth
    Director Innovation
    Fresenius Kabi Austria GmbH

    Daniela Pinter
    Master Student..
    University of Graz
  • 1500 - 1530
    Aseptic F&F of Soft Mist Inhaler: Project Experiences
    Share with attendants experiences from Respimat project start to product transfer and ramp-up. The facility is for a combination product based on a cartridge (aseptic liquid filling) and a soft mist inhalator. Describe in this presentation the experience of a project set-up such as project organization with tandems of experts, unique project plan, importance of design freeze, ...) How to do knowledge management along the project to ensure a successful start-up (from project to routine organization) by sharing experiences such as international assignments for project members, include external expertise from the network and other companies, etc. How to balance cost vs quality standards?
    Speakers

    Amanda Gilabert
    Focused Factory Respimat Manager
    Boehringer Ingelheim
  • 1500 - 1530
    Flexible Line and Lean Logistics for Packaging 
    In recent years, pharmaceutical market demand has shifted to favor smaller orders for some products as opposed to large-batch orders. The changeover time required between small-batch orders poses challenges to the industry’s supply chains since it can take up to 6-8 hour in the standard packaging lines. The new flexible line and new organizational model has the aim to be fast in performing the changeover in order to handle the small batches efficiently and to guarantee agility in responding customer demand.
    Speakers

    Alessandro Zanotti
    Manufacturing & Packaging Project Delivery Manager
    Johnson & Johnson

    Alessandro Sciacca
    Project Delivery Senior Manager
    Johnson & Johnson
  • 1530 - 1600
    Networking Break in the Exhibition Area
  • 1600 - 1630
    Multi Product Fill & Finish and Lyophilization
    Speakers

    Patrick Wieland
    Global Lead Business Development
    Bausch+Ströbel SE + Co. KG

    Richard Denk
    Senior Consultant Aseptic Processing & Containment
    SKAN AG
  • 1600 - 1630
    Visual Inspection in Sterile Manufacturing (ML)
    Speakers

    Gitte Bjørg Windfeldt
    Head of Data Science, Digital Transformation & Technology, PSQIT TEC
    Novo Nordisk A/S
  • 1630 - 1700
    Unique BFPC for Real-time Viable Air Monitoring
    The new EU GMP Annex 1 requires continuous environmental monitoring in production lines and validated rapid/alternative methods (RMM) are supposed to be a good option. However, the continuity of microbial measurements when transitioning from the traditional method to RMM has raised many questions. Here, we present a new and unique instrument for continuous monitoring, also known as a bio-fluorescent particle counter (BFPC), which combines real-time air microbial monitoring and the traditional growth-based method of agar sampling in a single device. It has three essential features to comply with regulations: 1) viable particle counting, 2) total particle counting, and 3) long-period of aseptic sampling on traditional agar medium for microbial identification, placed outside of clean area and reducing the risk of contamination. The real-time technology employs multi-angle scattered light pattern analysis and fluorescence spectra measurement resolved over 16 channels for real-time total and viable particle counting. The presentation will cover the method's validation approach and implementation in aseptic filling. We will explain the methodology for validating our BFPC that users can perform in-house. Finally, we will present the results of primary validation: excellent and consistent results for real-time viable counting compared to established growth-based method.
    Speakers

    Svetlana Kiseleva
    Chief Marketing Officer
    Plair SA
  • 1630 - 1700
    Lean, Compliant & Digital Quality Control Lab
    The management of fragmented source of information (different applications, xls/access, paper) represents an obstacle to achieve adequate and timely KPIs, root cause analysis, audit and inspections management and workload efficiency. Implementation of a state-of-the-art technology Laboratory Information Management System and ELectronic Notebook (LIMS/ELN) able to collect and manage all the information related to batch release and quality control flows in a biopharma company, allow to have full traceability of all day-by day activities generated by lab work and batch release, moreover in compliance with ALCOA requirements.
    Speakers

    Sara Del Carlo
    Quality Control Sr. Manager & Qualified Person
    Kedrion BioPharma
  • 1700 - 1730
    Panel Discussion with Speakers from Track 5 and Closing Remarks
    Speakers

    Ryan W. Waldhart
    Senior Manager of Manufacturing Science & Technology
    Grand River Aseptic Mfg Inc

    Patrick Wieland
    Global Lead Business Development
    Bausch+Ströbel SE + Co. KG

    Svetlana Kiseleva
    Chief Marketing Officer
    Plair SA

    Amanda Gilabert
    Focused Factory Respimat Manager
    Boehringer Ingelheim

    Ricardo Grilo
    Operations Director
    Laboratórios Atral S.A.

    Richard Denk
    Senior Consultant Aseptic Processing & Containment
    SKAN AG
  • 1700 - 1730
    Panel Discussion with Speakers from Track 6 and Closing Remarks
    Speakers

    Edoardo Schiraldi
    Corporate Program Manager
    Menarini

    Christoph Koeth
    Director Innovation
    Fresenius Kabi Austria GmbH

    Gitte Bjørg Windfeldt
    Head of Data Science, Digital Transformation & Technology, PSQIT TEC
    Novo Nordisk A/S

    Daniela Pinter
    Master Student..
    University of Graz

    Alessandro Zanotti
    Manufacturing & Packaging Project Delivery Manager
    Johnson & Johnson

    Sara Del Carlo
    Quality Control Sr. Manager & Qualified Person
    Kedrion BioPharma

    Alessandro Sciacca
    Project Delivery Senior Manager
    Johnson & Johnson
After the Event
Wed, 13 Dec
  • 0830 - 1630
    GAMP® Basic Principles Two-Day Training Course: Day 1
    Separate registration required. To learn more and register, visit this link: https://ispe.org/training/course/gamp-basic-principles-2-day-training-course

    This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
  • 0900 - 1300
    Facility Tour - Boehringer Ingelheim - SOLD OUT
    SOLD OUT! Boehringer Ingelheim settled in Spain in 1952. For almost 70 years, the company has been growing to be among the top twenty pharmaceutical companies in this country. Its headquarters are located in Sant Cugat del Vallès (Barcelona), with more than 1,500 employees. Boehringer Ingelheim Spain has two pharmaceutical production plants in Sant Cugat: - One plant for the manufacture of injectables and orals (capsules and, in the future, antidiabetic tablets).  - Another plant is dedicated to the manufacture of aseptic cartridges and packaging of the RESPIMAT® range of products (inhalers). In both facilities, Boehringer Ingelheim incorporates the latest technologies and new concepts of production, with integrated and process-oriented systems. The tour will feature a visit to the Production facilities (Fill & Finish and packaging) through a visitor’s corridor. Transportation and Lunch are provided! To reserve your spot, be sure to add this to your registration for $75 or stop at the onsite registration desk. Attendance is limited to 30.
  • 0900 - 1330
    Facility Tour - Grifols - SOLD OUT
    SOLD OUT! Grifols, a global healthcare company leader in essential plasma-derived medicines and transfusion medicine, is excited to host an on-site facility tour within the ISPE Pharma 4.0 and Annex 1 Conference in Barcelona. The walking tour will include a visit to the plasma fractionation facility and the aseptic filling and packaging areas. Transportation and Lunch are provided! To reserve your spot, be sure to add this to your registration for $75 or stop at the onsite registration desk. Attendance is limited to 18. Important Notice: No pictures allowed. Closed toed shoes are required for all attendees - no high heels permitted.
After the Event
Thu, 14 Dec
  • 0830 - 1630
    GAMP® Basic Principles Two-Day Training Course: Day 2
    Separate registration required. To learn more and register, visit this link: https://ispe.org/training/course/gamp-basic-principles-2-day-training-course

    This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.