AI Maturity Model for GxP Application: A Foundation for AI Validation

About the Author

Senior Manager

Deloitte GmbH WPG

Nico Erdmann, PhD, is Senior Manager at Deloitte Germany where he is part of a team dedicated to regulatory and compliance in the life sciences...

Rolf Blumenthal

AI Principal Consultant

Körber Pharma Software Freelance

Rolf Blumenthal is a Senior Consultant at Körber Pharma (formerly Werum) and has many years of experience in the pharmaceutical industry. He joined Werum in...

Ingo Baumann

Partner

Thescon GmbH

Ingo Baumann is Head of Delivery and a Partner at Thescon. He holds a diploma in chemical engineering from the European University of Applied Sciences...

Markus Kaufmann

GMP Auditor

Novartis

Markus Kaufmann is Certified Assessor for Software Process Improvement and Capability Determination (SPICE) and is working as Global GMP Auditor at Novartis in Basel, Switzerland...

Technical

Computer Software Assurance and the Critical Thinking Approach

1 March 2024

In 2022, the US Food and Drug Administration (FDA) issued their draft guidance “Computer Software Assurance for Production and Quality System Software”

Features

Digital Display Labeling in Clinical Supplies for Clinical Trials

1 March 2024

Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system-controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the...

Features

Evolving China’s Regulatory System in Alignment with ICH

1 March 2024

With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...

About the Author

Facilities of the Future: Meeting the Demands of Breakthrough Therapeutics

Emerging Leader Hacker to GAMPer in 10 Weeks

New Initiative Seeks to Back up ICHs Harmonization Mission

Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future

Q&A with ISPE Foundation Professional Development Grant Recipient Silas Tamufor

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