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Quality 4.0 – Advancing Pharmaceutical Quality Through Process and Data Science

Nuha Al-Hafez
Heike Roeder
Quality 4.0 – Advancing Pharmaceutical Quality Through Process and Data Science.

Just around the corner on 11-12 December, join us for a wealth of knowledge sharing, uniting industry experts to engage in discussions that unveil their insights and experiences through the 2023 ISPE Pharma 4.0™ and Annex 1 Conference.

One particularly intriguing facet of this conference is Track #2, titled Quality 4.0 – Advancing Pharmaceutical Quality Through Process and Data Science. It's no secret that digitalization has rapidly transformed the Life Sciences Industry, with a significant push from the challenges posed by the COVID-19 pandemic. The inherent value of data as an asset has been widely acknowledged, serving not only to enhance connectivity and supply chains but also to revolutionize product lifecycle management. The evolution of digitalization, with its profound emphasis on leveraging data to boost performance, enhance agility, prioritize customer centricity, and prevent failures, is steering our Pharmaceutical Quality System into uncharted territory known as Quality 4.0. In this track, we will embark on a journey through six captivating sessions, each hosted by industry leaders and experts, that will illuminate the path ahead in this transformative era of pharmaceutical quality.

Session # 1: Advancing Pharmaceutical Quality: The Knowledge Enabled Organization Paige Kane, Director Knowledge Management at MSD, will holistically share the concepts of knowledge management to enable knowledge flow. 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. Kane will also delve into the intricacies of digitizing and enhancing processes within both the Pharmaceutical Quality System (PQS) and the broader business ecosystem. Moreover, Kane will shed light on strategies for capturing and effectively harnessing the invaluable expertise embedded within our workforce to enrich our operational processes.

Session # 2: Join us for an engaging Fireside Chat with two seasoned digital transformation leaders, Teresa Minero, Founder & CEO at LifeBee and Heike Roeder, Vice President QA International at Cencora as they generously share their wealth of experiences on the critical topic of Organizational Development as a Priority for Successful Digital Transformation. With their vast expertise, Minero and Roeder will engage in an interactive discussion that delves deep into the following pivotal aspects:

  • Unveiling the Transformational Odyssey: they will illustrate the dynamic journey of going through digital maturity as a fundamental new organizational set-up and leadership 
  • Insights from the Field: Drawing from industry feedback and their real-life encounters, our speakers will provide invaluable insights into the challenges and triumphs of navigating the complex terrain of digitalization. 
  • Envision and share principles for successful organizational development as holistic Transformation

Session # 3: Advanced Data-Driven Process Performance and Product Quality Monitoring System (PPPQMS) for Real-Time Quality Decisions Line Lundsberg-Nielsen, Managing Consultant, Compliance Consulting at NNE will engage attendees in an insightful discussion and provide concrete illustrations of how the pharmaceutical quality landscape can be elevated through timely access to precise data. This accessibility empowers organizations to make informed, real-time quality decisions that can drive significant improvements in their processes and outcomes.

Session # 4: Navigating Quality Maturity and Digital Transformation to Create a Culture Beyond Compliance In this session, Maria Amaya, Lead External Advocacy North America (Quality Policy) at Genentech will discuss the pivotal role of quality culture in shaping quality maturity and will elaborate on the six sub-elements of ISPE APQ cultural excellence and we will elucidate their intricate connections with systems, data, processes, and the organizational framework. Amaya will turn the attendees attention towards the execution of digital strategies. These strategies are meticulously designed to elevate quality standards and enhance manufacturing efficiency and productivity. Furthermore, they foster a culture of quality within the organization, skillfully balancing compliance demands with the pursuit of a competitive edge.

Session # 5: Thomas Zahel, PhD, Head of Innovation at Körber Pharma Austria GmbH will be speaking about the 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 drug substance/ drug product specifications, relevant for patient safety and efficacy. This is beneficial over using process models from individual unit operations as they only predict intermediate quality and do not allow for assessing final product quality. Zahel will present how end-to-end process models can (1) correctly account for sources of variability in uncertainty quantification and (2) overcome the necessity to define acceptance limits for intermediate process steps.

Session # 6: Next Gen Pharma Quality Management: Unleashing the Power of a Modular Approach Mirco Thomas, Managing Director at Interfacing GmbH and Jérémie Arrault, Head of QMS at Galapagos NV will be Unleashing the Power of a Modular Approach, where they 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.

2023 ISPE Pharma 4.0™ and Annex 1 Conference