Maximilian Stroebe, PhD

Janssen Vaccines & Prevention (A J&J Company)
Senior Manager
Maximilian Stroebe, PhD, Senior Manager at Janssen Vaccines and Prevention, is an expert in data integrity, computerized system validation, and quality management. He has 19 years of experience in commercial and investigational medicinal products manufacturing and in all aspects of clinical trials at several major pharmaceutical companies in Switzerland, Germany, and the Netherlands. In his current role, he leads the quality oversight team for computerized systems, equipment, and facilities of a biotechnological pilot plant and the related quality control laboratories. Max co-authored the ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data and has presented at several ISPE Annual Meetings. He has been an ISPE member since 2013.

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Due to the growing digitalization of the industry, we are highly dependent on information technology (IT) systems and data. The basic ability to execute our pharmaceutical business and decision-making processes relies on the permanent availability of these IT systems and data to ensure compliance and efficiency of our business operations. But numerous factors—including criminal activities,...