This track asks a timely question: What does regulatory success look like when innovation keeps rewriting the playbook?
What Attendees Will Learn
Across this track’s sessions, speakers will dig into how organizations can:
- Build quality into facilities and processes from the start
- Translate evolving regulatory expectations into practical requirements
- Prepare for inspection in environments that are modular, digital, and global
- Apply risk-based thinking across product lifecycles
- Leverage—and govern—AI and automation responsibly
- Design quality functions that can scale with multi-product, multi-modality manufacturing
In short, attendees will walk away with actionable frameworks, implementation tools, and case studies they can put to work immediately.
Featured Topics and Voices Shaping the Conversation
“When Algorithms Lie: GxP Compliance vs Black Box Models,” presented by Ashley Moore, Smithers PDS
Many tools already function as black boxes—from predictive quality control modeling to natural language processing in standard operating procedures review. But what happens when those decisions can’t be explained?
This session reveals:
- Where ungoverned AI introduces compliance risk in regulated environments
- How to align intelligent systems with ISPE GAMP® 5 Guide (Second Edition), computer software assurance, and 21 CFR Part 11
- How to define intended use for intelligent systems, detect algorithmic drift before it becomes a deviation, and craft regulator-ready validation narratives
- Real-world case study examples leveraging AI, both positive and negative
This session offers helpful guardrails for anyone exploring automation in their digital future.
“Evolving Quality Risk Management (QRM): A Strategic Approach,” presented by Matthew Poch, Alnylam Pharmaceuticals and Tiffany Baker, ValSource Inc.
Expanding pipelines and facilities can multiply quality management risks exponentially. This session breaks down:
- What it takes to move from reactive risk management to a unified QRM strategy
- How to operationalize ICH Q9(R1) across an enterprise
- Why a “living” risk framework improves decision-making, governance, and resource allocation
Attendees will leave knowing how to turn QRM from an audit requirement into a competitive advantage.
“The ‘Flex-Force’ Facility: Operationalizing Agile Quality,” presented byKatherine Stemmer, JLL/Johnson and Johnson and Brad Sibbald, Kelly Science & Clinical
Flexible facilities need flexible quality. This session explores:
- Where traditional headcount models can break down in multi-modal manufacturing
- How functional service provider (FSP) models can create scalable quality assurance (QA) capacity
- Governance and culture practices for hybrid internal/external teams
- Real case studies where FSP models can support enabled launches and tech transfers
This is critical insight for any quality organization battling workload spikes, staffing shortages, or bandwidth bottlenecks.
Why This Track Matters
Professionals working in quality, technical operations; manufacturing; chemistry, manufacturing, and controls; regulatory affairs; or engineering, the Compliance and Quality can benefit from attending sessions in this track. Attendees will gain tools to help:
- Build future-proof processes that satisfy regulators
- Speed innovation without sacrificing control or integrity
- Avoid costly operational risk by designing quality in at the start
- Understand where regulators are headed—not just where they are today
- Bring practical takeaways back to your team, site, or global network
Perhaps most importantly: itframes quality not as a gate—but as an enabler of speed, safety, and sustainability.
Who Should Attend?
- QA/quality control leaders and practitioners
- Regulatory affairs professionals
- Manufacturing and technical operations teams
- Validation and commissioning roles
- Facility and capital project teams
- Anyone building, staffing, or managing a next-gen manufacturing environment
The future is already reshaping how pharma builds, validates, and runs facilities.
This track makes sure quality is right there shaping it—not racing to catch up.
Register for the 2026 ISPE Facilities of the Future Conference today, set for 2–3 February in San Diego, California, USA.
Register Now!>
