Thomas Zahel, PhD

Körber Pharma Austria GmbH
Head of Innovation
Thomas Zahel is Head of CMC Innovation Consulting at PAS-X Savvy of Körber Pharma Software Austria, with outstanding experience in statistics, algorithm development and turning complex challenges into easy concepts for our clients. His background is in bioprocess engineering and he holds a PhD in applied statistics for process development and validation. He is most passionate about developing new statistical methods and turn them into intuitive data science tools for consulting projects and features of our software inCyght. He has successfully helped top-ranked biopharmaceutical companies to develop, improve and validate their processes according to regulatory compliance.

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Process validation (PV) aims at reassuring a manufacturer of constant product quality. Moreover, it is a regulatory requirement to achieve licensure of a pharmaceutical product Failing to efficiently plan and execute activities here leads to increased time-to-market. Statistics play a pivotal role here, as is shown by the fact that in the 22 pages of the latest FDA guidance document on process...