Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
Featured Sessions
All session times are listed in Pacific Standard Time (PST). Find your personal viewing time on the World Clock.
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Compliance & Quality
Mon, 2 Feb
1045 – 1115
Compliance & Quality
Ashley Moore, Smithers PDS
The pharma industry is sprinting into an era of intelligent automation but what happens when AI stops playing by the rules?
From emerging use cases like predictive QC modeling to natural language processing in SOP review, machine learning is quietly infiltrating GxP systems. Unsurprisingly so, many of these tools function as black boxes, making decisions that are invisible to traditional validation frameworks. This session pulls back the curtain on the risks, blind spots, and compliance pitfalls of ungoverned AI in regulated environments.
We’ll explore how to bring AI into alignment with GAMP 5 (2nd Ed.), CSA, and 21 CFR Part 11, without slowing innovation to a crawl. Learn how to define intended use for intelligent systems, detect algorithmic drift before it becomes a deviation, and craft validation narratives regulators can trust.
Real-world case studies will help showcase scenarios where AI nearly got it right and where it went dangerously wrong. You’ll walk away with a tactical toolkit for risk-based oversight That’s agile, audit-ready, and future-facing.
1115 – 1145
Compliance & Quality
Matthew Poch, Alnylam Pharmaceuticals
Tiffany Baker, ValSource Inc
As pharmaceutical companies scale operations and expand portfolios, the complexity of managing quality risks increases exponentially. This presentation explores the evolution of Quality Risk Management (QRM) within a growing organization and the strategic implementation of a QRM Master Plan to ensure consistency, compliance, added value, and proactive risk-based decision-making. We will present a real-world case study detailing how a maturing company is transitioning from reactive, fragmented risk assessments to a structured, integrated QRM framework aligned with ICH Q9(R1) principles. The QRM Master Plan serves as a central guiding document to harmonize risk methodologies, plan for the creation and optimization of living (lifecycle) risk assessments, define governance, and embed risk-based thinking into core quality and operational systems such as change control, deviation management, supplier qualification, and product lifecycle management. Key outcomes include improved risk transparency, enhanced cross-functional collaboration, improved control strategies, and more efficient resource allocation - critical elements for maintaining product quality and patient safety in a dynamic regulatory environment.
1145 – 1215
1345 – 1415
Compliance & Quality
Amit Sharma, Solchem|ReveonAI
This session, “Reimagining Inspection and Audit Response Writing with GenAI,” explores a new, non-traditional approach to regulatory inspection and audit responses, moving beyond static, template-driven QMS tools toward a more adaptive, intelligence-driven model enabled by Generative AI.
The session highlights common industry challenges such as compressed regulatory timelines, inconsistent root cause analysis, weak or generic CAPAs, limited standardization, cross-functional silos, and insufficient supporting evidence. Issues that conventional QMS systems often struggle to address effectively.
A structured, end-to-end response framework is presented, spanning debriefing, planning, root cause analysis, drafting, review, and approval. Within each phase, GenAI is positioned as a decision-support and writing accelerator that improves clarity, speed, and consistency while maintaining human oversight.
The session also introduces Retrieval-Augmented Generation (RAG) to ground AI outputs in verified internal data, ensuring accuracy, traceability, and audit readiness. In addition, critical aspects of data security, confidentiality, and governance are also addressed. It emphasizes that enterprise AI solutions operate within strict data-protection boundaries, with no use of proprietary data for model training, supporting compliance with pharmaceutical regulatory and privacy requirements.
Overall, the presentation demonstrates that when implemented with strong governance and a human-in-the-loop approach, GenAI can significantly reduce response cycle times, improve writing quality, strengthen CAPA effectiveness, and enhance regulatory compliance—ultimately enabling more efficient, standardized, and defensible inspection responses.
1415 – 1445
Compliance & Quality
Afrah Mujeeb, Access Vascular Inc
1445 – 1515
Compliance & Quality
Katherine Stemmer, JLL/Johnson and Johnson
Brad Sibbald, Kelly Science & Clinical
As the biopharmaceutical industry transitions toward multi-modal, flexible manufacturing assets, the traditional fixed-headcount model for Quality Assurance (QA) has emerged as a critical bottleneck to operational agility. "Facilities of the Future" require a "Workforce of the Future"—one capable of dynamic scalability to match the peaks and troughs of campaign-based production, tech transfers, and rapid product launches. This session explores the strategic deployment of the Functional Service Provider (FSP) model within Shop-Floor Quality and Operational QA. Unlike traditional staff augmentation, which offers bodies without accountability, the FSP model embeds managed, specialized quality units directly into the site’s Quality Management System (QMS).
Panelists will dissect real-world case studies demonstrating how FSP partnerships have transformed fixed labor costs into variable operational expenses, effectively decoupling "headcount" from "capability." The discussion will focus on the practical mechanics of the "Flex-Force" model: How to maintain a "One Team" culture while integrating external partners; how to structure Quality Agreements to ensure shared accountability for "Right First Time" metrics; and how to utilize FSP teams for high-volume, repetitive tasks (e.g., batch record review, environmental monitoring trends) to free up internal Quality leadership for strategic oversight and continuous improvement. Attendees will leave with a blueprint for designing a resilient, scalable Quality organization that enables, rather than inhibits, the speed of modern manufacturing.
Panelists will dissect real-world case studies demonstrating how FSP partnerships have transformed fixed labor costs into variable operational expenses, effectively decoupling "headcount" from "capability." The discussion will focus on the practical mechanics of the "Flex-Force" model: How to maintain a "One Team" culture while integrating external partners; how to structure Quality Agreements to ensure shared accountability for "Right First Time" metrics; and how to utilize FSP teams for high-volume, repetitive tasks (e.g., batch record review, environmental monitoring trends) to free up internal Quality leadership for strategic oversight and continuous improvement. Attendees will leave with a blueprint for designing a resilient, scalable Quality organization that enables, rather than inhibits, the speed of modern manufacturing.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.