David Selby, David Selby, BSc, PhD, MCQI, has spent all his working life in the pharmaceutical industry, mostly in roles requiring knowledge of GMP and the regulatory environment. After some years in research and development at Glaxo, he moved to international GMP compliance auditing, before becoming responsible for the manufacture of tablets, and then antibiotics at the Glaxo site in Co. Durham, UK. He subsequently occupied the role of site quality assurance manager and of site manager. In 1998, he established his own consultancy, Selby Hope International, Ltd., specialising in the compliance of computerised systems and automated equipment used in pharmaceutical manufacturing. His clients include many of the major pharmaceutical companies, key engineering suppliers and a number of regulatory agencies. Selby also acts as a technical adviser to the Boards of Directors of a number of companies, and is eligible to act as a Qualified Person under EU Law. Selby has served for a full term of 9 years as a Director on the International Board of International Society for Pharmaceutical Engineering (ISPE), and in 2003-4 was elected Chairman, the first non-American to be so honoured. He continues to be involved in the many ISPE initiatives and the organisation of many courses. He was a founder member and Chairman of the GAMP Forum and is currently the Chairman of ISPE’s Product Quality Lifecycle Implementation (PQLI®) Executive Committee, responsible for producing guidance to facilitate the understanding of ICH Q8, Q9 and Q10.