The ISPE Pharma 4.0 Operating Model – Basis for the ICH Holistic Control Strategy – An Introduction

The introduction of advanced automation and the increasing interconnectivity of Industry 4.0 is not only revolutionizing the Pharma industry but also introducing many new challenges and production roadblocks. Understand why we need the Holistic Control Strategy concept in the ISPE Pharma 4.0 Operating Model, as the key element from development up to commercial production. Pharma 4.0 is the Holistic approach in the Supply Chain to make the ICH Control Strategy happen in manufacturing environments. We need the interdisciplinary collaboration of the different departments (QA/QC, CMC, Process Development, Manufacturing Operations, Engineering, Automation and IT) to design a robust and flexible production execution environment by design.

Learn Objectives

  • Understand the linkage between Industry 4.0 and Pharma 4.0 in regard to the regulatory impact
  • Learn the Pharma 4.0 Operating Model Elements and Enablers in the context of the ICH Q10 Pharmaceutical Quality System/PQS
  • Understand why the interdisciplinary cultural silo breaking collaboration is key in digitalization and bringing digital maturity into an organization

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pharma 4.0

Christian Woelbeling
Senior Director Global Accounts
Werum IT Solutions

Christian is Senior Director Global Accounts at Werum IT Solutions based in Lueneburg, Germany, part of the Körber Medipak Systems Group. Werum is the market leader in Manufacturing Execution Systems / MES Solutions for the Life Science industries, working for 17 out of the Global Top 30 Pharma Companies with more than 800 installations. He helds a Master Degree in Mechanical Engineering. Since more than 27 years working in Life Sciences Manufacturing IT, Christian has had great experience in all GMP related processes. He has broad activities inside the ISPE as Chairman of the Special Interest Group “Pharma 4.0”, ISPE “GAMP MES Special Interest Group” Co-Chair, ISPE GAMP Member at large of the European Steering Committee, “Knowledge Network Council” Chair, “PAT & Lifecycle Control Strategy” CoP Steering Member, ISPE Affiliate DACH Board Member.

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