Digitalisation

Objective

Reasons to attend this conference:

  • You will get an overview of current digitization trends in the pharmaceutical industry
  • You will learn how efficiency and quality can be improved through the implementation of digitalisation.
  • In various case studies of pharmaceutical companies, projects from practice are presented.

Background

New forms of digitalisation are finding their way more and more into the pharmaceutical industry. If the automation stage is already well advanced, topics such as AI, IOT and Industry 4.0 are waiting in the wings.
The conference will address these topics and present and discuss initial experience from established projects. The focus will be on GxP-relevant aspects from the perspective of the pharmaceutical industry and the monitoring authorities.

Target Audience

The event is directed at specialists from the pharmaceutical industry as well as at engineers and planners who have to deal with digitalisation projects.
It particularly addresses the departments:

  • IT
  • Production
  • Quality assurance
  • Engineering / Technology

Moderator

Yves Samson
Stefan Münch

Detailed Programme

Presentations - 28 March 2023

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
Presentations - 29 March 2023

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 Haefner, PSM

  • 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

CASE EVENT with a German CMO – Moving Quality Documents to the Cloud
Anja Koeleman, Vetter Pharma-Fertigung
Oliver Bosch, Epista Life Science Deutschland

  • Needs analysis and system selection
  • Process optimization
  • Validation
  • Organisational Change Management
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