David Selby , Ph. D., is president and founder of Selby Hope International Ltd., which specializes in the compliance of computerized systems and automated equipment used in pharmaceutical manufacturing. He is a leading consultant to the life science industry – particularly in the area of understanding and interpreting United States and European Union regulatory guidelines. A native and current resident of the United Kingdom, Mr. Selby’s career spans nearly 40 years in pharmaceutical industry roles requiring knowledge of Good Manufacturing Practice (GMP) and the pharmaceutical regulatory environment. He held multiple management positions over 29 years at Glaxo Wellcome (now GlaxoSmithKline). He was also deeply involved in the International Society for Pharmaceutical Engineering (ISPE). He was a director on the International Board of ISPE for nine years and currently serves as co-chairman of ISPE’s Process Analytical Technology (PAT) Community of Practice and co-chairman of the Community of Practice Council. As a founding member of ISPE’s Good Automated Manufacturing Practice (GAMP) Forum, Mr. Selby currently serves as co-chairman of the European Steering Committee and as a member of the GAMP Council. He is a contributing author to GAMP4 and a number of the GAMP Good Practice Guidelines. Dr. Selby earned his doctorate degree from University of Leeds and has a B.Sc. also from the University of Leeds.