PDA Good Digital Manufacturing Conference 2025

Topics we are looking for:

• 1. Digital Transformation
  • Real Use Case Studies with Lessons Learned
  • Collaborative Case Studies
  • Software and Connectivity Standards
  • Digital Maturity Model
  • Connectivity/Blockchain Technology/Cloud Solutions
  • Connecting Sensors and Machines via the Internet of Things for Interoperability
  • Dos and Don’ts for Successful Digital Transformation
  • Information Technology - Operational Technology
    
  • Measuring Digital Transformation Success
• 2. Application of Artificial Intelligence (AI) in Pharma
  • Real Use Case Studies with Lessons Learned
  • Regulatory Challenges and Opportunities
  • Impact of the EU AI Act on the Pharma Industry
  • Effects of U.S. FDA Guidance on Artificial Intelligence and Medical Products
  • Software Verification and Validation Protocol/Test Report
  • U.S. FDA Software Guidance
  • "Black Box" and "White Box" Testing
  • Process Analytics and Modelling
  • Model Use in Manufacturing – Level of Impact of Filing Requirements
  • Machine Learning/Deep Learning
  • Rule-Based Versus Machine Learning Algorithms
  • AI Validation
  • Success Stories: Qualification of AI Models in Different Applications
  • Generative AI in Pharma
  • Training Data Quality: Considerations for Quality of Training Data
  • Risk Profiles in AI Applications
• 3. Data Life Cycle Management
  • Data Accessibility/Data Adherence
  • Big Data/Real World Data
  • Data Analytics
  • Data Governance
  • Data Retention
  • Data Submission
  • BioCompute Format Accepted by U.S. FDA
  • Data Integrity/ALCOA+
  • Application of ANSI ISA-95
  • Data Security, Data Protection, and Data Privacy
  • Cyber Challenges and Cybersecurity
  • Information Security Management System According to ISO/IEC 27001 Standard
  • Digital Readiness and Preparing Your Data Ecosystem
  • Data Lakes
  • Single Source of Truth
  • Pathway from Data to Information to Decisions
• 4. Manufacturing and Quality Control
  • Computerized Systems Validation According to EU GMP Annex 11 and U.S. FDA CFR Part 11
  • Automation and Robots in Aseptic Manufacturing, Assembly, and Packaging
  • Equipment Fit for Industry 4.0/IoT
  • Factory of the Future
  • Digital Twins
  • Reduction of Human Interventions
  • Predictive Analytics
  • Digital Solutions to Improve Operational Efficiency
  • Machine-to-Machine and Machine-to-Human Interfaces
  • Augmented Reality/Virtual Reality for Equipment Maintenance
  • Automation of Laboratory Equipment/Processes
  • Leverage Digitalization for Effective Tech Transfers
  • Real-Time Release
  • Advanced Process Controls
  • In Silico Approaches for Product Development and Streamlining of PPQ Approaches
• 5. Sustainable Digitalization
  • Digital Solutions for Sustainable Manufacturing
  • End-of-Life Solutions for Equipment
  • Circular Economy
  • Replacement of Human Workforce by Automation
  • Preparing the Workforce for Industry 4.0
  • Link Between Digitalization and Sustainability
  • AI and Sustainability