Integrating Knowledge Management and Quality Risk Management

About the Author

Executive Director, Knowledge Management

PRST

Martin (Marty) Lipa has over 25 years of biopharmaceutical industry experience, including over a decade in Knowledge Management (KM). Marty is currently Senior Research Fellow...

Valerie Mulholland

Snr Consultant

GMP Services Ltd

Valerie Mulholland is the CEO of GMP Services Ltd and is a GMP/Quality Consultant in Europe. She is a practitioner in the area of Quality...

Anne Greene, PhD

Professor

TU Dublin

Anne Greene leads the Pharmaceutical Regulatory Science Team (PRST) in Technological University Dublin, where she is also a senior lecturer and director of several MSc...

Technical

A Sustainable Approach to Steam Quality Management

1 March 2024

The world is beginning to grasp the huge challenge of achieving net-zero carbon emissions, or carbon neutrality, by 2050. Many countries have committed to achieving this ambitious goal. As a major global industry, the pharmaceutical sector has a significant role to play. For thermal energy–intensive industries, such as pharmaceutical manufacturing, the long-term future options to maintain...

Technical

Concluding Compliance Challenges with Validation 4.0

13 March 2024

As the pharma industry moves to an ambitious Validation 4.0 paradigm, computerized systems play a pivotal role in enabling the rapid transition. Innovation and agility in computerized system validation (CSV) received a strong push in the second half of 2022 with the publication of the FDA draft guidance on “Computer Software Assurance for Production and Quality System Software”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...

About the Author

Facilities of the Future: Meeting the Demands of Breakthrough Therapeutics

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

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