ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation

Learning Level: Basic
Time: 1100 - 1230 EDT 
Session Length: 1.5 hour

The ISPE Baseline® Guide: Pharma 4.0™ provides the structural capabilities framework needed for realizing successful and lasting transformations. It contains tools and advice for companies in achieving their digitization and financial goals while maintaining/improving product quality and meeting regulatory requirements and expectations. In addition, this Guide outlines various starting points, prerequisites, governance structures, and strategies for achieving transformational success tailored to an organization’s size, risk tolerance, flexibility, and maturity level.

The Industrial Digital Transformation is more than just an approach to implement digital technologies; it is a shift in mindset and a fundamental shift in the way companies operate their business to deliver value for patients and customers. Smart organizations will not only have capabilities but will also be highly adaptable.

The Guide covers all areas of transformation including the benefits of a holistic control strategy, opportunities opened by digital transformation in quality management, and the foundational processes and principles for interconnected plant architecture. It includes organizational change management practices to help workers adapt to confounding challenges from new technologies and acquire the necessary skills to thrive in a changing culture. 

This webinar will provide an introduction to the Baseline Guide, organized by chapter topics.

  • Chapter Structure & involved Chapter Leader
  • Principles of Pharma 4.0 & Digital Transformation Strategies
  • Holistic Control Strategy
  • Quality Management in the Digital Age
  • The Human Element People, Organization & Culture
  • Navigating Regulations in a Digital World
  • Process & Data Mapping
  • Plug & Produce: Principles & Challenges
  • Engineering Design and Construction
  • Enabling Technologies
  • Collection of Case Studies

Learning Objectives

  • Introduce the basics of a Pharma 4.0 Digital Business Transformational Journey.
  • Learn how to use the Baseline Guide and the Digital Business Maturity Assessment.
  • Advertise the Pharma 4.0 Baseline Guide

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Michelangelo Canzoneri
Global Head of Group Smart Manufacturing
Merck KGaA Darmstadt, Germany
Yvonne Duckworth, PE
Fellow - Digital Technology, Associate
Paige E. Kane, PhD, CPIP
Director Knowledge Management
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Christian Wölbeling
Executive Industry Advisor
Körber Pharma Software GmbH
Vinzenz Zauner
Managing Director
Memo3 GmbH
Thomas Zimmer, PhD
VP European Operations