GAMP 5 was published in 2008 to great acclaim around the world. Just having the guide published does not mean the benefits it offers will automatically be achieved. This seminar will look at some of the corporate and culture challenges to effective implementation. The seminar will include workshop elements to explore challenges and how they might be resolved. At the conclusion of this session, participants will be able to:
Dr. Guy Wingate is currently Vice-President & Compliance Officer for Global Manufacturing & Supply at GlaxoSmithKline and has 19 years of experience working in the pharmaceutical industry. At GSK he has held several roles including overall responsibility for quality for one of GSK's largest manufacturing sites, responsibility for QA Technology Strategy, leading a major revision to the GSK corporate Quality Management System, and overall responsibility for Computer Compliance standards and implementation. Dr. Wingate has been involved with the GAMP COP for 17 years in various capacities; most recently he has chaired its governing body GAMP Council 2000-2010 and led the Task Teams producing GAMP®4, GAMP®5 and the GAMP® Good Practice Guide on Compliant Electronic Records and Signatures. Currently he is Co-Chair of ISPE's Task Team writing a new ISPE Guide for the Science and Risk-Based Approach for the Specification, Design, and Verification of Facilities, Utilities, and Equipment Systems which is based on ASTM E55 principles. Wingate was elected to the ISPE International Board of Directors in 2008. He is a Chartered Engineer and holds a BSc, MSc, and PhD from University of Durham in computing, advanced electronics, and engineering science respectively. He is widely published in journals and books, and regularly chairs and speaks at conferences in the US and Europe. Dr. Wingate is also Visiting Lecturer for the University of Manchester's M.Sc. course on Pharmaceutical Engineering Advanced Technology (PEAT) and Dublin Institute of Technology's accredited M.Sc. course on Validation Sciences.