ACDM Conference | March 4, 2025
QFINITY’s COO Marcus Schwabedissen and Senior Executive Consultant Frank Henrichmann will be at the ACDM Conference in Prague. Frank Henrichmann will give a presentation on:
Introduction to the ISPE Good Practice Guide Validation and Compliance of Computerized GCP Systems and Data
Tuesday, March 4, 2025 at 11:35 AM to 1:05 PM
Recently released regulatory guidance documents and the release of the ISPE GAMP 5 Second Edition have triggered an update of the ISPE GAMP Good Practice Guide “Validation and Compliance of Computerized GCP systems and Data”. Maintaining the principles and framework of the First Edition, GAMP Good Practice Guide has been revised and expanded in 2024 to address quality, integrity and compliance aspects, such as:
- AI/ML Systems in Clinical Trails
- Systems at Clinical Sites
- Systems in Decentralized Clinical Trials
- Real-World Data / Real-World Evidence
- Audits and Inspection Readiness in an Outsourced Environment
- Systems involved Good Clinical Laboratory Practice
You can find more information about the ACDM conference here.
