Shane P Smith
ExtLe Solutions Ltd., UK
Biography
Shane P Smith is the Managing Director of ExtLe Solutions Limited, a company based in Cambridge in UK. He has over 30 years of experience in Industrial Analytical Chemistry, with well over half of that time spent in the Pharmaceutical sector. From 2004, he has worked for GlaxoSmithKline’s world class extractables and leachables team at Stevenage in the UK, managing projects for global cross-site project teams, and having ultimate responsibility for extractables and leachables sections of regulatory files submitted to agencies in North America, Europe and other territories. He has left GlaxoSmithKline in early 2016 to pursue a career as an Independent Consultant.
Abstract
Abstract : Six essential do’s and don’ts for an effective GMP extractables and leachables strategy