CASSS Sharing Science Solutions US Manufacturing Virtual Summit 2026

The CASSS US Manufacturing Virtual Summit examines the practical requirements for expanding pharmaceutical manufacturing capacity. Held on May 7, 2026, the one-day program brought industry, academic, and regulatory perspectives together across four sessions of presentations and panel discussions. Topics include onshoring, facility development, operational readiness, workforce training, supply-chain resilience, inspection preparation, FDA PreCheck, and post-approval changes. The listed materials also include a scientific program and summary infographic. This course is relevant to manufacturing, CMC, regulatory affairs, quality, engineering, and supply-chain professionals seeking a broader view of how facilities, people, processes, and regulation interact during capacity expansion.

Learning Objectives

• Evaluate insights and innovative approaches for U.S. manufacturing onshoring in comparison with European manufacturing landscapes.
• Analyze strategies for building state-of-the-art manufacturing facilities and executing operational playbook changes at an unprecedented pace.
• Design capability architectures to develop future workforce capacity and enhance supply chain resilience for the emerging U.S. biomanufacturing wave.
• Understand regulatory compliance, inspection-readiness approaches, and informational frameworks surrounding the FDA PreCheck Program.
• Navigate the complexities of post-approval changes and develop compliant, efficient solutions across commercial and clinical manufacturing operations.

The original summit comprised four main sessions; the store list below includes presentations, session material, and supporting documents. It does not imply a separate video for every entry. CASSS registration, membership, live Q&A, On Demand access, credit, and certificates are not included with the file purchase.

Topics

• Accelerating US Manufacturing Onshoring: EU Landscape Insights and Innovative Approaches

• Building It Is the Easy Part, Changing the Playbook Is Harder

• Capability Architecture: Engineering the Future Workforce for Supply Chain Resilience

• CASSS Welcome: Virtual Summit US Manufacturing 2026 Introduction

• Delivering State-of-the-Art Manufacturing Facilities at an Unprecedented Pace

• Ensuring Inspection Success

• Post-Approval Changes: Navigating Complexity, Delivering Solutions

• Regulatory Aspects Introduction: Informational Slides on FDA PreCheck Program

• Session I: Infrastructure and Building (including Panel Discussion)

• Session II: Regulatory Aspects (including Welcome, Summary, and Concluding Remarks)

• Virtual Summit Manufacturing 2026 Scientific Program and Summary Infographic

• Workforce Capacity & Training: Building the Pipeline for the US Biomanufacturing Wave

Faculty

Karim Kacimi – Novo Nordisk Inc.

Julia Edwards – Eli Lilly and Company

Jared Auclair – Northeastern University

Mary E. Farbman – Merck & Co., Inc.

Cyrus Agarabi – CDER, FDA

Nina Cauchon – Amgen Inc.