CoP Session: Pharma 4.0
4:00 PM – 4:45 PM | Red Level Press Box
Navigating Digital Transformation in Pharma: Insights from the ISPE Pharma 4.0TM Community of Practice
This session will introduce the ISPE Pharma 4.0™ Community of Practice, highlighting its subcommittees, their missions, and goals. We will review the Pharma 4.0 Baseline Guide and two new Good Practice Guides (Holistic Digital Enablement and Validation 4.0), emphasizing key factors for successful digital transformation. The session will highlight modern, continuous, data-driven validation approaches and strategies for navigating digital transformation in the pharmaceutical industry, including the integration of advanced technologies like AI, ML, and IoT to improve decision-making, agility, speed to market and patient outcomes. Key enablers include robust knowledge management, critical thinking, data governance, and fostering a culture of continuous learning. This session will highlight challenges like cybersecurity, legacy systems, and regulatory compliance, offering adaptable best practices aligned with ISPE GAMP and cultural frameworks to drive innovation and operational excellence.
Attendees will gain insight into:
- The structure and objectives of the ISPE Pharma 4.0™ Community of Practice.
- Key factors for achieving digital transformation excellence in the pharmaceutical industry, as well as modern, continuous, data-driven validation approaches.
- Strategies for integrating advanced technologies like AI, ML, and IoT, along with enhancing decision-making, agility, and patient outcomes through digital transformation.
Yvonne Duckworth, PE, CRB
Nuha Al-Hafez, Sr. Director, Quality & Compliance, FUJIFILM Diosynth Biotechnologies
Michelle Vuolo, Head of Quality & Compliance, Tulip Interfaces, Inc.
Biography:
Yvonne Duckworth, PE, CRB
Yvonne is a fellow in digital technology at CRB with over three decades of expertise in the life sciences industry. Yvonne has extensive automation engineering and digital technology expertise in the pharmaceutical, biotech, oligonucleotide, and cell & gene therapy industries. She is a recognized Pharma 4.0™ thought leader, as evidenced by her numerous speaking engagements at national and international conferences. These include ISPE, PDA, Concept Heidelburg, TIDES and Interphex events. Yvonne is a co-chair of the ISPE Pharma 4.0™ Community of Practice as well as the co-chair of the ISPE Pharma 4.0™ Holistic Digital Enablement Subcommittee. She was a lead chapter author of the ISPE Pharma 4.0 Baseline Guide which was published in Dec 2023.
Nuha Al-Hafez, Sr. Director, Quality & Compliance, FUJIFILM Diosynth Biotechnologies
Nuha is a seasoned leader with over 30 years of experience in the pharmaceutical industry, spanning R&D, Operations, and Quality across the innovative, generic, and contract manufacturing sectors. She has held key leadership roles at Patheon, Teva Canada, Merck KGaA, Roche, and Fujifilm.
Her expertise includes Quality Management Systems, Quality Risk Management, Data Governance, Product and Process Development, and Inspection Readiness. Nuha has led global and site-based quality initiatives, driving compliance, operational excellence, and a strong quality culture aligned with regulatory expectations and industry standards.
Michelle Vuolo, Head of Quality & Compliance, Tulip Interfaces, Inc.
Michelle Vuolo is currently the Head of Quality at Tulip Interfaces, Inc., a platform developer that allows manufacturers of many industries to build digital content to manage their operations. Before joining Tulip, Michelle spent over 24 years in the biopharmaceutical and medical devices industries in quality control laboratories, engineering technical support, quality assurance management, and computerized systems compliance. Michelle has a strong understanding of the needs of the life sciences industry and is motivated to evolve stagnant ways of meeting compliance requirements, especially as it relates to the 4.0 world.
