PDA Good Aseptic Manufacturing Conference 2025

Topics we are looking for:

• 1. Pharmaceutical Quality System
  • Quality Risk Management
  • Role of Quality Assurance Department/Personnel
  • Root Cause Investigation and Determination
  • Corrective and Preventive Actions
  • Continuous Improvement
  • Management of Non-Conformities
  • Expectations & Experience of National/International Regulators/Inspectors
  • Feedback by FDA, PIC/s, WHO, and Other Countries/Organizations/Regulators
  • Case Studies Based on Recall Analysis
  • Quality Oversight and Requirements
• 2. Contamination Control Strategy (CCS)
  • Quality Control Strategy (Microbial, Endotoxin/Pyrogens, Particles)
  • Process Knowledge
  • Case Studies of CCS Implementation Including Effectiveness Check
  • Integration of CCS in Pharmaceutical Quality System
  • Environmental and Process Monitoring & Trending
  • In-Process Controls
  • Digital Tools
  • How Operators Can Support CCS
• 3. Premises and Barrier Systems
  • Retrofitting of Existing Installations Versus New Installations
  • Cleanroom & Facility Design
  • Quality by Design Principles
  • Moving from Traditional Cleanroom Design to Restricted Access Barrier Systems/Isolators
  • Hydrogen Peroxide Bio-Decontamination Cycle Development and Validation
  • Chemical Indicators, Biological Indicators, and Enzyme Indicators Application
  • Air Flow Visualization/Smoke Studies/ Computational Fluid Dynamics Simulations
  • Best Practice in Glove Integrity Testing
  • Reduction of Glove Interventions on Existing Lines
  • Gloveless Isolator
  • Application of EN ISO 14644
  • Cleanroom Classification/Qualification
  • First Air Principle and Impact of Further Airflow
  • Guide to Specific Requirements by Product Type
  • Alignment of Facility and Equipment Design to Fulfill the Aseptic Requirements
• 4. Equipment and Utilities
  • Robotics Application/Design of Robotic Solutions
  • Automation in Aseptic Filling
  • Material and Equipment Transfer, Limitations, and Best Practices
  • Ready-to-Use Material Introduction Technologies (Non-Touch Transfer, E-Beam, Hydrogen Peroxide, Hyperspeed Tunnels, etc.)
  • Cleaning, Disinfection, Sterilization Including Validation
  • Decontamination Airlocks
  • Case Studies on the Sterilization of Indirect Product Contact Parts
  • Design Considerations for Utility Systems
• 5. Personnel
  • Qualification, Monitoring and Training
  • Digital Training Modalities/VR Training Including Training Effectiveness
  • Transfer of Personnel
  • Determination of Number of Personnel
  • Gowning
  • Access Limitations/Disqualification
  • Personal Hygiene
  • Strategies to Recruit Skilled Workforce (Related to Personnel Shortage)
• 6. Environmental Monitoring and Quality Control
  • Advanced/Rapid Micro Methods
  • Bioburden Test
  • Sterility Test
  • Data Trending
  • Viable/Nonviable Particles
  • Quality Control of Small Batch Sizes
• 7. Aseptic Process Simulation (APS)
  • Aseptic Manipulations/Interventions
  • Process Simulation Test Plan with Quality Risk Management
  • Defining High-Risk Interventions
  • Batch Size/Sample Size Considerations
  • Bracketing Approach with QRM
  • Determination of Number of Aseptic Process Simulations for Successful Validation
  • Parameters for Successful Validation
• 8. Manufacturing
  • Shortages in Critical Raw Materials/Components/Products
  • Cost Increase in Energy, Water, and Supply Materials
  • Affordability of Drug Products Versus Manufacturing Cost
  • Patient Benefits Versus Manufacturing Cost
  • Sterilizing Filtration/Filter Integrity/PUPSIT
  • Container Closure Systems/Container Closure Integrity
  • Reducing Manual Interventions
  • Aseptic Connections/Sterile Connectors
  • Closed Systems
  • Integrity of Single-Use Systems and Development of Analytical Methods
  • Lyophilization
  • Blow-Fill-Seal/Form-Fill-Seal
  • Application of EU GMP Annex 1 Requirements on New Modalities (e.g., ATMPs)
  • Quality on the Shop Floor/Quality Oversight
  • Manufacturing Solutions for Toxic/Hazardous Substances
  • Small-Scale Batches
• 9. Partnering and Cooperation in Aseptic Manufacturing
  • Relationship CDMO and Contract Giver
  • Challenges in Different Company Sizes of Contract Givers and Contract Acceptors
  • Quality Systems Including Quality Agreements
  • Project Management in Outsourcing
  • Sourcing/Selection of CDMOs
  • Increasing Expectations to CDMOs Regarding Quality and Service
  • Price Negotiation and Economical Challenges
  • Technology Transfer (Manufacturing Process/Analytical Testing)
  • Health, Safety, and Environment
  • From Product to Solution
  • Expectations for Suppliers Not Working Under GMP Regulation
  • Defining Responsibilities to Comply with the Regulation
  • Quality Oversight of CDMOs
  • Influence of EU GMP Annex 1 on Sterile Medicinal Product Supply Chain
• 10. Sustainability in Aseptic Manufacturing
  • Profitable Economy Based on Degrowth
  • Sustainability Versus Quality Assurance
  • Eco-Design Guidelines for Machinery and Cleanrooms
  • Eco-Balancing of Products and Processes
  • Lifecycle Assessment Calculations
  • Disposal Practices – Today and Tomorrow
  • Biosafety
  • Bio-Waste Treatment
  • Water, Waste, and Energy Reduction Programs (Equipment and Infrastructure)
  • Reduction of Plastics and Waste Water
  • Equipment and Process Design for Material Waste Separation/Sorting
  • Cleaning as Pathway for Re-Usage of Material
  • Reverse Manufacturing Lines/Disassembly
  • Material/Value Recovery of Equipment After Use/At the End-of-Life
  • Measures for Equipment Lifetime Elongation
  • Circular Economy
  • Sterilization Impacts
  • Design of Facility/Installation to Support Saving Resources
  • Packaging Designs and Material Selection
  • EU Proposal for Packaging and Packaging Waste Regulation