Breaking with Tradition: Laying the Foundation for Validation 4.0

About the Author

Head of Quality

Tulip Interfaces

Michelle currently leads Quality at Tulip Interfaces, Inc, who develops and sells a frontline operations platform where manufacturers of many industries can build digital content...

David Margetts

CEO

Factorytalk Co., Ltd.

David Margetts is the CEO of Factorytalk, and an advisor, consultant, and technical expert in the areas of compliance and information technology. David’s background and...

Technical

Risk- And Science-Based Media and Buffer Mixing Validations

1 March 2024

The validation of media and buffer mixing is a continuing area of resource constraint in the pharmaceutical industry. These validations require materials, validation associates’ time, and the use of equipment and processing areas. This article proposes a risk-based life cycle for minimizing mixing validation resource inputs, with the objective of optimizing validation efforts through the use...

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

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