Consultant, Pharma Biotech

Phone: +44(0)1751 432999
Country: United Kingdom

David Selby has 40 years of experience in the pharmaceutical industry, primarily in roles requiring knowledge of GMP and the regulatory environment. He is eligible to act as a Qualified Person under EU Law. With this breadth of experience, Dr. Selby is currently focused on auditing, risk management, pharmaceutical quality systems and all aspects of validation and qualification. He helps companies prepare for regulatory inspections (both EU and FDA) and has developed the IRCA Accredited Pharmaceutical GMP auditing course.

Dr. Selby spent several years in research and development at Glaxo, before moving into international GMP compliance auditing and then becoming responsible for the manufacture of tablets and then antibiotics at the Glaxo site in County Durham, UK. Subsequently he occupied the role of Site Quality Assurance Manager and most recently was the Site Manager.

Dr. Selby served for a full term of nine years on the board of directors of the International Society of Pharmaceutical Engineering (ISPE). In 2003-2004, he was elected Chairman of ISPE and was the first non-American to be so honored.  He has been involved in many ISPE initiatives and the organization of many conferences.  He is a founder member and chairman of the GAMP® Forum and has chaired and is currently a member of ISPE’s PQLI Management Committee.