Why should you attend?

Applying Risk-Based Thinking under Annex 1
Understand how regulators interpret risk-based approaches in aseptic manufacturing, moving beyond “zero-risk” mindsets toward defensible, inspection-ready strategies.

Designing and Sustaining an Effective Contamination Control Strategy (CCS)
Learn how to build, maintain, and annually reassess a CCS using practical tools, APS outcomes, monitoring data, and lifecycle thinking.

Aseptic Process Simulation (APS): Challenges, Expectations, and Pitfalls
Gain insight into APS design, execution, and interpretation for complex products and ATMP processes, including common deficiencies seen during inspections.

Human Factors and Operator Interventions in Aseptic Manufacturing
Explore how personnel behavior, interventions, and organizational controls impact sterility assurance—even in highly automated environments.

Environmental Monitoring, Trending, and Data Integrity
Understand how to design robust environmental monitoring programs, manage excursions, and use trending data to support quality and regulatory decision-making.

Endotoxin Control Strategies: LAL vs Recombinant Methods
Examine the scientific, regulatory, and operational considerations when selecting and validating endotoxin testing methodologies.

Advanced Fill/Finish and Barrier Technologies
Learn about gloveless and fully automated fill/finish operations, isolator-based systems, and the practical considerations for implementation and validation.

Robotics and Automation in Aseptic and ATMP Manufacturing
Assess where robotics adds real value, where new risks emerge, and how automation is viewed through the lens of Annex 1.

Sterilizing Filtration Validation and Regulatory Expectations
Understand how to design and justify filtration validation strategies for downstream biologic manufacturing in line with current inspection practices.

Single-Use Systems and Material Risk Management
Explore risk assessment, lifecycle management, and regulatory expectations for single-use technologies in aseptic processing.

Extractables & Leachables and USP <665> in Practice
Gain practical insight into implementing USP <665>, managing E&L risks, and aligning engineering, quality, and regulatory requirements.

Container Closure Integrity (CCI): Expectations and Implementation
Learn how CCI fits into overall sterility assurance and what inspectors expect to see in terms of strategy, testing, and documentation.

Digitalization, Smart Manufacturing, and Pharma 4.0 under Annex 1
Examine how digital validation, data integrity, and smart manufacturing concepts can support—not complicate—regulatory compliance.

Inspection Readiness for ATMP Manufacturing
Understand how inspection expectations differ for ATMPs and how to prepare facilities, documentation, and teams accordingly.

ATMP Manufacturing Interfaces: From CMC to Aseptic Operations
Explore the challenges of scaling advanced therapies, aligning CMC strategy with aseptic manufacturing, and managing risk during technology transfer.

Future-Proofing Aseptic and ATMP Manufacturing
Gain perspectives on balancing compliance, innovation, and operational efficiency in an evolving regulatory and technological landscape.