Artificial Intelligence in Pharmaceutical Manufacturing: From Foundations to Implementation

Moving Beyond AI Hype - Towards Practical, Compliant Implementation Artificial intelligence is creating new opportunities across pharmaceutical manufacturing, quality operations and regulatory affairs. Yet implementing AI in a GxP-regulated environment presents challenges that extend far beyond the technology itself. How do you identify the right use cases? How do you maintain data integrity, establish appropriate controls and validate systems that do not always produce deterministic outputs? And perhaps most importantly, how do you move from exploring AI possibilities to developing an implementation strategy that your organisation can confidently take forward? Join the ISPE Nordic Affiliate for an intensive, two-day training course led by Chris Dayton, Co-Founder and CEO of QualityAssured.ai. Designed specifically for pharmaceutical and biotechnology professionals, this hands-on training combines AI fundamentals, regulatory considerations and practical implementation strategies. Two Days. One Practical Outcome. Leave with an AI implementation roadmap tailored to your own organisation. Rather than focusing solely on theory, this course takes participants through seven progressive workshops, applying the learning to a specific AI use case. Throughout the training, you will develop the building blocks of an implementation strategy, from identifying the opportunity and assessing regulatory risks to defining system architecture, data governance, validation requirements and organisational readiness. By the end of the course, you will have developed a structured AI implementation roadmap that can support discussions and decision-making within your organisation. What Will You Learn? Participants will gain practical knowledge and frameworks to: Understand AI in a GxP context: Explore how large language models work, their capabilities and limitations, and what makes them different from traditional validated software. Identify meaningful use cases: Assess opportunities for AI across pharmaceutical manufacturing, quality and regulatory operations. Design controlled AI systems: Understand system architecture, data management, security, prompting and appropriate human oversight. Navigate regulatory expectations: Explore relevant FDA, EMA and European regulatory frameworks, including emerging guidance for AI in pharmaceutical manufacturing. Apply risk-based validation: Understand how GAMP 5, ICH Q9(R1), data integrity principles and context of use inform AI validation strategies. Plan for implementation: Develop a practical roadmap addressing governance, validation, organisational readiness and deployment considerations. Course Content The two-day programme covers seven interconnected topics: AI Foundations Prompting Fundamentals and Text Generation AI System Architecture Data Management, Embeddings and Retrieval-Augmented Generation (RAG) Regulatory Frameworks and Expectations Risk-Based AI Validation Deployment Strategies and Real-World Use Cases Interactive workshops are integrated throughout the programme , allowing participants to apply the concepts to a practical use case and progressively develop their implementation plan. Who Should Attend? This training is designed for professionals involved in evaluating, implementing, validating or governing AI within pharmaceutical and biotechnology organisations. It is particularly relevant for: Quality Assurance and Quality Control professionals Regulatory Affairs and Compliance specialists Validation and Computerised Systems professionals Manufacturing, Engineering and Technical Operations teams IT, Digital Transformation and Pharma 4.0 professionals Managers and leaders responsible for AI strategy and implementation No prior AI or programming experience is required. A basic understanding of GMP/GxP principles is recommended. Meet the Instructor Chris Dayton Co-Founder & CEO, QualityAssured.ai Chris Dayton is the Co-Founder and CEO of QualityAssured.ai, where he leads the development of AI systems designed specifically for pharmaceutical quality and regulatory environments. His work focuses on developing AI solutions that support pharmaceutical quality operations while maintaining strict GMP requirements. Before founding QualityAssured.ai, Chris spent over a decade in biopharmaceutical manufacturing and technical operations at Resilience, Thermo Fisher Scientific and BioMarin Pharmaceutical. His background spans biologics manufacturing, technology transfer, quality investigations and regulatory audit support. Combining practical pharmaceutical manufacturing experience with AI system development, Chris brings a valuable industry perspective to the opportunities and challenges of implementing AI in regulated environments. This training was previously delivered at North Carolina State University's Biomanufacturing Training and Education Center (BTEC) in May 2026. ISPE Nordic Affiliate is now bringing the course to Copenhagen, offering professionals across the Nordic and Baltic life sciences industry the opportunity to gain practical knowledge of AI implementation in GxP-regulated environments. Tickets & Registration Choose the registration category that applies to you: ISPE Members: €1,300 Non-ISPE Members: €1,550 2027 ISPE Nordic Annual Meeting Participants: €1,100 (exclusive access code required) Special Offer for Annual Meeting Participants Attending the ISPE Nordic Affiliate Annual Meeting on 1–2 March 2027? Take advantage of our exclusive €1,100 AI training rate! To access this special offer, you must first register for the 2027 ISPE Nordic Affiliate Annual Meeting: https://billetto.eu/en/e/ispe-... Once registered, you will receive an exclusive access code to unlock the discounted AI training ticket. Simply enter your code during the Billetto checkout process to access the €1,100 participant rate . https://billetto.eu/en/e/ispe-...