This webinar is an introductory session into Good Automated Manufacturing Practices - better known as GAMP®.
Our speakers from the ISPE UK Emerging Leaders team intend to cover the key principles of GAMP® with a focus on GAMP®5.
The session is aimed at those with little or no experience with GAMP®/GAMP®5. The target audience are Emerging Leaders i.e. students, recent graduates and young professionals.
GAMP® aims to provide industry good practice in an effective and practical way to promote consistent system life cycle approach with an objective to ensure that computerised systems are fit for intended use. The guide takes into consideration patient safety, product quality and data integrity and is intended to be used across different GxP arenas.
Presented by Sabrina Dey and Mohammed Gangat
Sabrina Dey joined Otsuka March 2019 as Manager, Global Quality Operations where her role covers CSV auditing as well as other quality activities. Prior to joining Otsuka, Sabrina held various roles from QA associate, QA officer to QA Manager for Summit Therapeutics where she was responsible for oversight and management of numerous QA activities including, conduct of GxP audits, training and SOPs oversight and management. Sabrina is a pharmacist by training where she worked at Boots the chemist for few years before joining the pharmaceutical industry; Sabrina also worked at Quantum Pharmaceuticals (Clinigen Company) as a QA release Pharmacist. She achieved PhD in Tissue Engineering and Drug Delivery from the University of Nottingham in 2010. Sabrina is a member of GAMP® UK CoP committee as well as ISPE Emerging Leaders Committee. Sabrina enjoys hiking and cooking different cuisines outside of work.
Mohammed is a Computer System Validation Consultant and Quality System Manager at CSV Ltd. He has experience in GMP, Validation and Process Engineering in the Pharmaceutical and Oil and Gas sector. Mohammed currently works as a CSV Engineer for WuXi Biologics. He is also the Secretary of the ISPE GAMP® UK CoP committee as well as a member of both the UK and Ireland ISPE Emerging Leaders committee.
Outside of work, Mohammed enjoys staying fit, reading and travelling. He is a keen football fan and an avid supporter of Manchester United.