PDA Good Aseptic Manufacturing Conference 2026

Topics we are looking for:

• 1. Pharmaceutical Quality System
  • Quality Risk Management
  • Role of Quality Assurance Personnel
  • Quality on the Shop Floor/Quality Oversight
  • Deviation Handling, Root Cause Investigation
  • Corrective and Preventive Actions (CAPA)
  • Continuous Improvement and Change Control
  • Management of Non-Conformities
  • Phase-Appropriate Aseptic Processing
  • Experience and Expectations from Regulatory Inspections
  • Regulatory Feedback from EMA, U.S. FDA, PIC/S, WHO, etc.
  • Case Studies Based on Recall Analysis
• 2. Contamination Control Strategy (CCS)
  • Microbial, Endotoxin, and Particle Control
  • Process Knowledge and CCS Effectiveness
  • CCS Integration into the PQS
  • Environmental and Process Monitoring/Trending
  • In-Process Controls
  • Digital Tools Supporting CCS
  • Operator Support, Behavior, and Training
  • Metrics and Implementation to Change and Deviation Management
  • Cross-Contamination Control Strategy
  • Material Transfer Concept
  • Product-Specific CCS
  • CCS for API and Incoming Material, PPM, etc.
• 3. Premises and Barrier Systems
  • Cleanroom and Facility Design
  • Quality by Design Principles
  • RABS vs. Isolators
  • Hydrogen Peroxide Decontamination - Cycle Development and Validation
  • Air Flow Visualization/Computational Fluid Dynamics (CFD) Simulations
  • First Air and Airflow Considerations
  • Glove Integrity Testing
  • Reduction of Interventions
  • Gloveless Isolators
  • Cleanroom Classification/Qualification (EN ISO 14644)
  • Product-Type-Specific Design Guidance
  • Material Transfer Process and Qualification (Limitations and Best Practices, e.g., Filling Line Equipment & RTU)
  • EU GMP Annex 1 Affecting Legacy Facilities and Equipment
  • RTU and Transfer Technologies (e.g., No-Touch Transfer E-Beam, Hydrogen Peroxide)
  • Cleaning, Disinfection, and Sterilization (including Validation)
  • Sterilization of Indirect Product Contact Parts
• 4. Equipment and Utilities
  • Robotics and Automated Solutions
  • Smart Manufacturing and Aseptic Filling Automation
  • Equipment for Transfer and Utilities (Limitations and Best Practices)
  • Utility System Design
• 5. Personnel
  • Aseptic Quality Culture
  • Qualification, Monitoring, and Training
  • Digital and VR Training Modalities
  • Personnel Transfer and Access Limitation
  • Gowning (e.g., Overalls, Socks, Goggles)
• 6. Environmental Monitoring and Quality Control
  • AI in QC Workflow
  • Rapid/Advanced Methods
  • Real-Time Monitoring (e.g., BFPC)
  • Bioburden and Sterility Testing
  • Enzymatic/Biological Indicators (including VPHP)
  • Data Trending and Handling
  • Viable and Nonviable Particle Measurement
  • QC for Small Batch Sizes
• 7. Aseptic Process Simulation (APS)
  • Aseptic Manipulations/Interventions/Reduction Strategies
  • Risk-Based APS Design
  • High-Risk Interventions
  • Small vs. Larger Batch Size/Sample Size Considerations
  • Campaign-Style Aseptic Process Simulation
  • Bracketing & Matrixing Approaches
  • Continuous Process Validation
  • Number and Parameters for Successful Validation
  • Operator Training and Qualification
  • End of Production APS
• 8. Manufacturing
  • Raw Material and Component Shortages
  • Cost Pressure and Affordability
  • Patient Benefit vs. Manufacturing Cost
  • Filtration and PUPSIT
  • Container Closure Systems and Integrity
  • Manual Intervention Reduction
  • Aseptic and Closed Systems
  • Lyophilization
  • Blow-Fill-Seal/Form-Fill-Seal
  • EU GMP Annex 1 for New Modalities
  • Manufacturing of Small-Batch (Personalized) Pharmaceuticals
  • EU GMP Annex 1 for Manufacturing of HPAPIs, e.g., ADCs
  • Supply Chain Logistics
  • Technological Flexibility/Agile Equipment
• 9. Partnering and Cooperation
  • CDMO and Sponsor Collaboration
  • Small vs. Large Organization Challenges
  • Quality Agreements and Systems
  • Outsourcing and Project Management
  • Technology Transfer
  • GMP Compliance Responsibilities
  • Regulatory Oversight of CDMOs
  • Supply Chain Considerations under EU GMP Annex 1
• 10. Sustainability in Aseptic Manufacturing
  • Impact of AI Usage on Sustainability
  • Profitable Economy: Growth by Quality - Degrowth by Quantity
  • Sustainability vs. Quality Assurance
  • Eco-Design for Facilities and Equipment
  • Life Cycle Assessment and Eco-Balancing
  • Disposal and Bio-Waste Treatment
  • Implication of PFAS/Plastics Control
  • Water, Energy, Waste Reduction
  • Reduction of Wastewater
  • Cleaning for Re-Use
  • Reverse Manufacturing/Disassembly
  • Equipment Lifetime Extension
  • Circular Economy in Manufacturing
  • Sustainable Packaging and Material Selection
  • EU Packaging Waste Regulation