Operational Excellence in Action: Solutions for Today's Complex Challenges
Come in with the problem you're stuck on and the promotion you're working toward. Leave with a playbook for one and proof of progress on the other.
Mid-Career Leaders Agenda
Why This Agenda is Built for You: You're managing teams, running projects, and solving the operational problems that don't have a textbook answer, usually all at once, usually with a deadline. This agenda focuses on the implementation-grade sessions that map to your real work: risk-based control strategies you can apply to a live specification problem, AI and automation deployment in GMP environments, facility and utilities cases from people who've actually built the thing, and the regulatory pathways for getting a new method accepted. Every session answers one question: what do I bring back Monday?
Your Monday Morning Impact: Return with a risk-based control-strategy framework you can put to work immediately, an AI-in-GMP deployment approach you can pilot, a vendor shortlist for a project you're running right now, and the command of current thinking that the next title requires. Plus the network: the peers and the people one rung ahead who become the contacts you call when you're stuck.
Is This You?
This agenda is built for you if you're an:
- Engineering Manager, Project Manager, or Associate Director
- Senior Process, Validation, or CQV Engineer or Lead
- Quality Manager or Manufacturing Supervisor
- Professional with 6 to 15 years in pharma who's implementing strategy, not setting it
- Someone building the case for their next role
Setting enterprise strategy and approving the capital? See the Senior Leadership Agenda.
Newer to pharma? The Pharma Foundations Agenda is built for you.
What You'll Walk Away With
- A risk-based control-strategy framework (ICH Q6-aligned) you can apply to an active specification or validation problem, and use to reduce redundant testing.
- An AI-in-GMP deployment playbook you can pilot on a defined workstream, drawn from the automation and AI-governance sessions.
- A vendor shortlist for a live project: single-use systems, HVAC for a cell-therapy suite, WFI generation, lab sizing, evaluated rather than just browsed.
- A named contact who's already done it: someone who's implemented the thing you're about to, so you skip the trial-and-error.
- The promotion case: demonstrated command of the field's current thinking, which is exactly what the next title requires.
SUNDAY SCHEDULE
| Time | Session | Type |
|---|---|---|
| 0700 – 1800 | Registration Open | Registration |
| 1300 – 1600 | Choose Your Focus: Option A: Accelerating Innovation in Sustainable Sourcing & Ops Choose this if you are a manager or supervisor working with AI, ML, and lifecycle data on a real sourcing and manufacturing pipeline. Built for your level. Option B: Annex 1 in Action: Designing Facilities That Reduce Risk Choose this if you own facility or contamination-control work; hands-on CCS, HVAC, and QRM design with regulatory-observation pitfalls mapped. Option C: From Single Sites to Standardized Manufacturing Network Choose this if you run tech transfer and want the network-standardization and ICH Q12 detail behind it. | Workshop |
| 1600 – 1800 | Sunday Social Find the peers who have already solved what you are stuck on. One good contact here can save you a month of trial and error back at the plant. | Networking |
| 1900 – 2230 | 2026 ISPE FOYA Banquet & Awards Celebration Please note that separate registration is required. See the award-winning facilities up close. These are the projects and people whose approaches you will want to borrow. | Special Event |
MONDAY SCHEDULE
| Time | Session | Type |
|---|---|---|
| 0700 – 0800 | Continental Breakfast | Meal |
| 0800 – 0930 | Opening General Sessions
Sets the industry context your projects sit inside. The Patient Speaker reminds you why the work matters when you are deep in a deviation review. | General Session |
| 0930 – 1030 | Networking Break in Expo Hall Scout vendors for the project you are running now. Come with your active shortlist and start narrowing it. | Networking |
| 1030 – 1100 | Choose Your Focus: Option A: Early Regulatory Alignment to Implement NGS at GMP Scale Choose this for a practical Regulatory CMC playbook, with real FDA and PMDA consultation pathways for getting a novel method accepted. Option B: Ambition Zero Carbon at an AstraZeneca Biologics Flagship Choose this if you are executing site-level sustainability and want the implementation detail behind a 98% emissions cut. | From Breakthrough to Bedside |
| 1100 – 1130 | Choose Your Focus: Option A: Fit-for-Purpose QA and RA for ATMPs Choose this for where the bottlenecks actually are: QC turnaround, batch review, deviation handling, and risk-based fixes you can bring straight back. Option B: A Structured Path to Sustainable Pharma Manufacturing Choose this for a maturity-based operational-improvement framework if reliability and energy are your remit. | From Breakthrough to Bedside |
| 1130 – 1200 | Choose Your Focus: Option A: Rethinking HVAC Design in Cell Therapy Choose this for a concrete facility-design risk-assessment comparing three HVAC and BSC configurations. The kind of method that saves you multiple costly front-end studies. Option B: Successful Business Cases for Sustainability Initiatives Choose this if your near-term challenge is getting a project funded rather than designed. | Multiple Tracks |
| 1200 – 1330 | Networking Lunch in Expo Hall Sit with people one rung ahead of you. Lunch conversations are where you learn what the next role actually requires. | Meal/Networking |
| 1330 – 1400 | Choose Your Focus: Option A: Growing mAb Capacity in an Operating Commercial Facility Choose this for a brownfield expansion run in a live facility: phased construction, minimized shutdown windows, dual USDA and EU readiness. If you have ever built while keeping production running, this is your session. Option B: Sustainability Modeling Through EcoDesign (GSK) Choose this if lifecycle and EcoDesign modeling maps to your work. Option C: People, Capability & Workforce of Delivery Choose this if team-building and career growth are your focus this trip. | Multiple Tracks |
| 1400 – 1430 | Choose Your Focus: Option A: Flexibility: Planning for Future Growth in Manufacturing (Promega) Choose this for how to design flexibility in: adjacencies, oversized spaces, planning for future automation, with the cost-versus-benefit math. Option B: From Planning to Patients: Lilly's QC Lab Model Choose this if lab design is closer to your work; a replicable QC-lab model across sites. | From Breakthrough to Bedside |
| 1500 – 1600 | Networking Break in Expo Hall Follow up on the morning's vendor leads. Book the real conversations now. | Networking |
| 1600 – 1630 | Choose Your Focus: Option A: Identifying Water Sustainability Opportunities (Fluor, 3R strategy) Choose this for a practical Reduce, Reuse, Recycle framework for high-purity water and CIP, presented by the engineers who did it. Option B: Process Modeling for Analytical Lab Sizing Choose this if capital-project lab sizing is a current pain; a dynamic-simulation method that beats spreadsheet guesswork. | Multiple Tracks |
| 1630 – 1700 | Choose Your Focus: Option A: Scaling PRINT® for High Dose Treprostinil Delivery (Liquidia) Choose this for a full bench-to-commercial scale-up story ending in a 2025 FDA approval. The engineering decisions behind taking a platform to commercial reality. Option B: Water, Water Nowhere, Not a Drop to Waste Choose this for the water-strategy ROI case if utilities are your domain. | Multiple Tracks |
| 1700 – 1730 | Choose Your Focus: Option A: Engineering a Sustainable Shift in mWFI Generation (SCHOTT, CRB) Choose this for a specific WFI membrane-redesign with a phased implementation that kept production running. Technical and regulatory detail you can adapt. Option B: Write Right: Essential Skills Digital Tools Can't Replace Choose this if writing or owning URS documents is on your plate and you want to keep them defensible as AI and automated validation tools reshape the work. | Multiple Tracks |
| 1745 – 1915 | Welcome Reception in Expo Hall | Networking |
TUESDAY SCHEDULE
| Time | Session | Type |
|---|---|---|
| 0700 – 0800 | Continental Breakfast | Meal |
| 0800 – 0930 | Morning General Sessions
A senior-leader keynote is a window into how the people above you think about industry direction. Useful intelligence for positioning your own work. | General Session |
| 0930 – 1030 | Networking Break in Expo Hall | Networking |
| 1030 – 1100 | Choose Your Focus: Option A: Automated ATMP Manufacturing, Consistency & Quality Choose this for how automation and robotics cut variability in ATMP processes, and how teams translate it into responses to real regulatory observations. Option B: Beyond Standardization: GMP Facility Delivery at Scale (Lonza) Choose this for the reuse and qualification mechanics behind platform-based delivery. | From Breakthrough to Bedside |
| 1100 – 1130 | Choose Your Focus: Option A: Risk Based Control Strategies to Enable Lifecycle Agility Choose this for an ICH Q6-aligned, risk-based control-strategy framework with biologics case studies that reduce redundant testing and ease post-approval change. The bring-it-back session of the conference for you. Option B: Integrated Systems for Reliable GMP Operations Choose this if cross-system EAM, QMS, and ERP integration is your current build. | Multiple Tracks |
| 1130 – 1200 | A Risk-Based Approach to Standardized Single-Use Design A live-facility case with a hard number, 69% contamination-risk reduction, using a risk-scoring framework you can replicate. Concrete, defensible, transferable. | Systems That Deliver Reliably |
| 1200 – 1415 | Membership Meeting and Awards Lunch - Open to All Attendees Recognition and networking over a long lunch. A relaxed window to meet people across the society. | Meal/Awards |
| 1415 – 1545 | Dessert Reception in the Expo Hall Last expo-floor window before it closes at 1530. Close your vendor evaluations and collect follow-up commitments. | Networking |
| 1545 – 1715 | Choose Your Focus: one session per time slot: 1545 – 1630 Option A: Are Leaks Always a Failure? Science vs Perception Choose this if you want to challenge entrenched quality thinking, moving leak management from perceived contamination risk toward simple, science- and data-driven risk analysis. Option B: Bridging Strategies for Platform Devices Choose this if platform device strategy is on your plate, modular development, platform control strategy, bridging modules, and the regulatory path for combination products. 1630 – 1715 Option A: Innovative Sustainability Execution for LEED Platinum Choose this if facility performance and reliability are your focus, applying LEED-driven design within a live GxP environment through a real retrofit case study. Option B: AI-Assisted Verification & Validation Choose this if SaMD validation is on your plate, integrating AI into V&V workflows while staying compliant with FDA 21 CFR Part 820, IEC 62304, and ISO 13485. | Multiple Tracks |
| 1900 – 2300 | Tuesday Night Celebration at Topgolf National Harbor Included with the In-Person All Access Pass, the add-on fee for the Tuesday Night Celebration is $225 for all other registration passes. The fun one, and the easiest place to turn a session contact into an actual relationship. Bring the people you met in sessions. | Special Event |
WEDNESDAY SCHEDULE
| Time | Session | Type |
|---|---|---|
| 0800 – 0900 | Continental Breakfast | Meal |
| 0900 – 1215 | Closing General Sessions
The Global Regulatory Town Hall puts global regulator direction in one room, the foresight that lets you plan your compliance work proactively instead of reacting. Worth staying for if regulatory touches your projects. | General Session |