Pharma 4.0 & Digitalisation

Introduction: Digitalisation in GxP environment: Between Mantra and Reality
Yves Samson, ECA DI&IT Compliance Interest Group
Stefan Münch, ECA DI&IT Compliance Interest Group

• Inhibitors
• Triggers
• Enablers
• Pitfalls
  
  

Digitalisation from the Inspector’s Point of View
Dr Arno Terhechte, GMP Inspectorate / Bezirksregierung Münster, Germany

Influence of Digitalisation on the Future Work of Quality Departments
Jürgen Schmitz, GSK Biologicals

• From Paper to Data
• Critical thinking
• Review by exception
• From control to continues improvement to Digital Twin
• Validation today and tomorrow
• What will change for Quality?
  
  

Case study – Digitalisation for Construction Management of Large Biopharmaceutical Plant
Marick Paris-Cadet, Technip Energies

• Case study: on-going construction site for a large biotech project localized in north of France, > 500M€ investment
• Coordination between client, engineering company, multiple subcontractors (60+)
• Methodology & Digital tools used for studies management and construction management
  • Collaborative BIM for 3D model, synthesis activity
  • Construction workfront/schedule, digital solution foron-site supervision for construction, inspection…
• Feedback & Added value
• Way forward: road map to full digitalisation, virtual reality / augmented reality
  
  

Automated Validation - Enabling Better Data Reliability and Integrity in Life Sciences
Eva Kelly, ERA Sciences

• System agnostic presentation discusses the increased use of automated validation solutions
• Reduction in manual transcription Errors
• Centralized management of validation documents and records
• Effort Commensurate with risk - ability to leverage unscripted, scripted and exploratory testing
• Configuration to address True Copy Record concerns

Advanced Monitoring of Production Process Using IIoT System
Milis Nikolic, Galenika

• Current challenges with efficiency and monitoring production proces
• Identifying critical points in the process
• How IIoT systems can help
• System Demonstration
  
  

Digitalisation and Automation: How to Avoid Losing from Day One, Preventing Successful Transformation to Fall Short
Ana Cláudia Pinho, BIAL - Portela & C.ᵃ
Many transformations are addressed as Digital Transformations instead of business transformations.

• Planning transformation
• Rethink processes
• Use automation to avoid inefficient use of resources
  
  

Implementation of Pharma 4.0 at the German CDMO PSM GmbH
Thorsten Häfner, PSM
Julian Petersen, groniger & co

• Complete paperless pharmaceutical production
• Generation of real-time data for faster batch releases
• Use of virtual twins for higher productivity
• Use of robotics for better process monitoring
• Elimination of humans for repetitive and critical process steps
  
  

Are Digitalisation and Artificial Intelligence a Double-Edged Sword in Pharma and Healthcare?
Marco Reiss, Paul-Ehrlich-Institut

• 'What is really meant with digitalisation and AI in pharma and healthcare?
• New perspectives and chances of digitalisation and AI in a hyperconnected pharma an healthcare sector
• Impact and (potential) risks of further digitalisation on the field of pharma and healthcare
• Do we need a guiding framework? Critical reflections, overthinking
  
  

AI Supported Intervention Detection and Classification in the Aseptic Core
Christoph Köth, Fresenius Kabi Austria

• FrEDIS - Fresenius Event Detection Information System is a pilot system live in routine production which in the current setting allows the detection and classification of human interventions in the aseptic core
• The development of such a system not only lead to new insights into aseptic manufacturing but also required an innovative (XAI based) approach to better understand AI decisions. This approach also enables a GMP validation where AI no longer acts as a black box
• Depending on the project progress results of discussions with relevant authorities should be available at the date of the conference