ISPE Webinar with QFINITY | 05. June 2025
On June 5, 2025, our Senior Executive Consultant, Frank Henrichmann, will be speaking at the ISPE webinar “Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems.” This free webinar is aimed at professionals with an intermediate level of experience and will explore the challenges involved in auditing and oversight of computerized systems in accordance with Good Clinical Practice (GCP) guidelines. Special focus will be placed on clinical site systems.
Webinar Topics:
Importance of Clinical Data: Understanding the critical role of data from clinical sites in the success of clinical trials and the risks associated with inadequate system validation or oversight.
Regulatory Expectations: An overview of EMA guidelines on computerized systems and electronic data in clinical trials, with an emphasis on compliance, data integrity, and system validation.
Challenges for Sponsors: A discussion of the difficulties sponsors face in establishing robust oversight of systems used at clinical sites, particularly in decentralized and hybrid trial models, to ensure regulatory compliance and data integrity.
This webinar is based on the “GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (2nd Edition).” It offers practical insights and best practices for system validation and effective collaboration between sponsors and clinical sites.
About the Speaker:
Frank Henrichmann brings extensive expertise in quality management and computerized systems and will share valuable insights from his work at QFINITY.
Registration:
Interested participants can register for the ISPE webinar 2025 here.
