Claudia Nolte, MSc

Director, Global Pharmacovigilance & Regulatory Quality Assurance (PVRQA) at CSL Behring

Claudia Nolte is Director, Global Pharmacovigilance & Regulatory Quality Assurance (PVQA) within Global Quality of CSL Behring, being located in Marburg, Germany. In the current role she is responsible for CSLBs’ global PV Audit Program, as well as for other aspects of the PV Quality Management System including Inspection Preparation and Management, Deviation and CAPA Management, 3rd Party Quality Management, Change Management, and Continuous Improvement.

Claudia holds a Master of Science in Pharmaceutical Medicine from the University of Surrey, Guildford, UK and has been in the pharmaceutical industry for more than 30 years; more than 15 years thereof in various positions within Quality Assurance. Since the implementation of GVP in Europe, she has been responsible for the strategical, tactical and operational PV Audit Plan set up, maintenance and execution. Furthermore, she has prepared, accompanied and hosted numerous PV/GCP Inspections from various Health Authorities including FDA, Health Canada, Swissmedic, Paul-Ehrlich Institute, MHRA, and ANSM.

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Title: Remote PV Audits and Inspections

  • How the pandemic changed the audit and inspection landscape
  • Challenges and potentials of remote audits and inspections