ACDM Conference | 4 March 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 the following topic:
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
More information about the ACDM conference can be found here.
