Klaus Finneiser

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Acino Pharma AG
Head QMS & Strategy
Klaus Finneiser, PhD, holds a PhD in chemistry (15N-NMR spectroscopy) from the University of Siegen, Germany. He started his career in the chemical industry where he gained experience in analytical chemistry, worked with universities to develop methods for monitoring enzyme fermentation pro-cesses, and supported other development and pilot projects. He then worked for five years in the dyestuff and chemical division of Ciba-Geigy before moving into the pharmaceutical branch (now Novartis) in Switzerland. During his 20 years in quality control and global quality operations he was involved in many quality initiatives and improvement projects. As a delegee in the EFPIA group for ICH Q9, he came across quality risk management. After leaving Novartis, he joined Ferring and later Acino, where he established a modular quality management system based on ICH 010. Since 2017, he has supported industrial clients in quality improvement and remediation projects.

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Figure 1: A global supply scenario with cross-country and cross-cultural interfaces
Features
Operational Risk Management in Global Supply Scenarios

The current regulatory framework in the pharmaceutical industry places pressure on marketing authorization holders (MAHs) to demonstrate quality oversight, and a systematic risk management process is a prerequisite for avoiding compliance and productivity pitfalls. This article focuses on options to improve day to- day operations and to ease decision-making by integrating operational risk...