ISPE Annual Meeting

Registration Open

2025 ISPE International Emerging Leader Hackathon Day 2

From Imposter to Impact: Reinventing Your Career with Confidence

Implementing an AI Solution in a Pharma 4.0 Context

The Decision Process for Continuous Biomanufacturing

Integrated Process for Drug-Device Combination Products

Facilitating Analytical Procedure Changes via ICH Q14

Sunday Social

2025 ISPE FOYA Banquet & Awards Celebration

16th Annual ISPE 5K Run/Walk

Registration Open

Continental Breakfast

Welcome to the ISPE Annual Meeting & Expo

Remarks from the Executive Chair

Transforming Pharma Manufacturing: Sanofi's Journey Towards Digital Excellence in the Pharma 4.0 Era

One Billion More Heartbeats: My Journey Through Heart Transplantation

Conference Highlights

Networking Break in Expo Hall

Expo Hall Open

Career Center in the Expo Hall

BMS’s Journey to a Tech-Enabled Global Transformation

Novel Technology Applied in Biologics Manufacturing

Decentralized Manufacturing - Regulatory Considerations

Building Quality Culture via Software Quality Engineers

2025 ISPE Facility of the Year Awards (FOYA) Category Winners Showcase

How to Be Sustainable, Annex 1 Compliant and Competitive

Regulations & CI - Contradict or Complement

Navigating Through the ATMP Guidance and Regulations

Impact of Fleet Management on Distributed Manufacturing

Successful Business Cases for Sustainability Initiatives

Digital Transformation in Cell Therapy Manufacturing

Managing the Compliance of Agentic AI in GxP Process

Navigating Regulatory Challenges of cATMP Delivery

Industry Update on Transportable and POC Manufacturing

Trust in the Digital Age: Blockchain’s Role in Pharma

LEED v5: Advancing ESG & Sustainability

Networking Lunch in Expo Hall

Paving the Path: Our Continuing Journey to Sustainability Excellence

A Practical Guide to AI Deployment in a GMP Environment

Designing for Pharma 4.0 - The Practical Considerations

Engineering Cold Storage at Scale

Transitioning from V-Model to Science & Risk-Based C&Q

Process Control for ATMPs by Digital Data Management

Facility Innovation: Automation and Process Flow

Winning in Life Sciences: The Human Connection

From Sustainability Goals to Governance

Modular Plants: A New ISPE Pharma 4.0 Good Practice Guide

Updated & Approved ASTM E2500 Standard: What Changed?

Harness Operational Data to Accelerate Decarbonization

Reinventing Machines: Shaping the Backbone of Pharma 4.0

Connecting the Dots to Achieve Process Understanding

Achieving L3.1 Process Intensification - Lisure M++ UltraPilot

Navigating FDA Compliance: 7356.040 & QMS Success

Accelerating Cell Therapy Manufacturing Through Modular Automation and Innovation

Networking Break in Expo Hall

Smart Manufacturing Driving Pharma 4.0 Transformation

Juggling Game: Pharma 4.0, Products, M&A, Sustainability

Gazing Into the Crystal Ball of Stability

Digital Vision Twin - Cut Downtime, Boost Productivity

Contamination Control Through a Phased Crisis Management and Recovery Action Plan

Innovations in Decentralized Clinical Trials and Tech

Building Resilient Pharmaceutical Supply Chains

How to Transform Engineering Organization at Scale

Regulatory Reliance & ICH Q12: Accelerating Adoption

Supply Resilience and Lessons Learned from the Pandemic

NextGen R&D Laboratories: Strategy and Execution

Maturity Assessments: Your Catalyst for Transformation

AI/ML in Regulatory Decisions: Compliance & Innovations

Leveraging Competition to Drive Sustainability

Readying for Major Changes to Single-Use: PFAS, USP <88> and <665>

Powering Performance: The Fusion of Talent, Suppliers & Operations

Welcome Reception in Expo Hall

Women in Pharma® Monday Night Networking Event

Registration Open

Continental Breakfast

Opening Remarks

Giving Back to the Industry - The ISPE Foundation

Unlocking Excellence: Takeda’s Quality Transformation

Scaling mRNA Impact Through Platform, Culture & Digital

Welcome Words on Behalf of the Carolina-South Atlantic Chapter

ISPE Career Center in the Expo Hall

Networking Break in Expo Hall

Expo Hall Open

Case Study: Cleaning Validation Design Transfer

Breaking Down a Global Dossier and Collaborative Review

Future-Proof QA: From Documentation to Control Objective

Merging, Managing & Scaling Supply Chain Resilience

The BMS EU Cell Therapy Facility, Project Triton!

Navigating Batch Release by Connecting Production Silos

Leadership Strategies and Approaches to Transform CSV

Use & Validation of 7% VPHP in Isolated Filling Lines

Pharma's Future: Blueprint for a Resilient Supply Chain

Simulation-Driven Solutions for Cell Therapy MFG Ramp-Up

Progress on Use of Reliance Pathway for CMC PAC

The Frontline to Patient Access: Advancing Second-Line

Regulatory Impact on Digital Health Technologies in DCT

Bridging the Future of Your Digital Enterprise

Enhancing Sterility Assurance: H2O2 Decontamination RABS

Innovative PAC Reliance/Collaboration Cloud-based Dossier

Adapting a mAb Facility for Gene Therapy Production

Membership Meeting and Awards Lunch - Open to All Education Attendees

Dessert Reception in the Expo Hall

Strategic Procurement amid Global Trade Uncertainties

Challenges in Developing Mutation-Agnostic Gene Therapy Approaches

Expanding Horizons: VHP Role in FDA Cat. A Steralization

Oligo Manufacturing: Balancing Current vs. Future Needs

Safety & Well-Being in High-Hazard Manufacturing

New GAMP AI Guide Overview and Key Concepts

Beyond the Pilot: The AI Adoption Playbook

Integrated Dynamic Bioprocessing Upstream Scale-up

CO2 Reduction Effort and Measurement During the Construction

Enabling Pharma 4.0 via Data Standards and Interoperability

Tuesday Night Celebration

Continental Breakfast

Registration Open

Opening Remarks

Regulatory Fireside Chat

Crisis Management and Partnership with FDA

Refreshment Break

Global Regulatory Town Hall

Closing Keynote Presentation

Closing Words and Adjournment