ISPE GAMP DI PRESENTATION #PLA2019


Takeaways of the last published GAMP DI guide related to #eDataLifeCycle for labs

Abstract

GAMP (Good Automated Manufacturing Practice ) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.

ISPE GAMP Community of Practice (CoP) is active within ISPE Knowledge Network and awarded for its outstanding work balancing quality, safety, and compliance with technical innovation and progress related to Computerized Systems Validation & Compliance and Data integrity.

In 2017 ISPE GAMP CoP started to publish GAMP® Records & Data Integrity (RDI) Guide series.

Learn about how eData Life Cycle and Computerized Systems Life Cycle interrelationships can benefit organizations in developing and raising their data integrity awareness, with takeaways of last published GAMP RDI Guide related to #eDataLifeCycle for Labs.

 

Presenter

TDeRudder Paperless Lab Academy

Name: Tom De Rudder

Title: ISPE GAMP CoP Europe Co-chair

Company: ISPE

 

Mr. De Rudder has +15 years’ experience in the Pharmaceutical Industry with expert knowledge in Computerized Systems GxP requirements & validation. He works as Site eCompliance/Computerized Systems Team Lead at Novartis. He drives continuous improvement to meet and sustain compliance, also active as a volunteer in ISPE GAMP Community of Practice.

ISPE paperless lab academy

ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit Pharma association serving its members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. ISPE’s core members, working as volunteers are active in Communities of Practice, publishing leading industry guidances and sharing expert knowledge to create high-quality, cost-effective GxP solutions.

 

www.ispe.org