From January 2021 I am only working 3 days per week, typically Tuesday to Thursday. I am a chemist with a Masters degree in analytical chemistry. I have over 45 years experience of pharmaceutical manufacture, control and quality management. In 2016 I was awarded an honorary Doctor of Science degree by Kingston University, London, for services to pharmaceutical quality management.I have been a Partner, Executive Director and then Vice President with NSF Health Sciences since February 2005. Prior to that I worked for Eli Lilly and Company for over 30 years, with various roles culminating in the role of Senior Quality Consultant in their Global Quality Systems division. I have broad experience, particularly with quality control laboratories and the manufacture of solid dosage forms and active pharmaceutical ingredients.I have been eligible to act as a Qualified Person since 1985 and am a past chairman of the Royal Society of Chemistry’s Qualified Person Assessor panel.I am a Chartered Chemist and Fellow of the Royal Society of Chemistry. I am also a Fellow of the Chartered Quality Institute (CQI) and a Chartered Quality Professional. I am an Honorary Life Member and former chairman of the CQI’s Pharmaceutical Quality Group.I am a former member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing and GMP ad hoc group and was EFPIA topic leader on the ICH Expert Working Group which prepared the Q9 guideline on Quality Risk Management.I am an Honorary Lecturer on Pharmaceutical Quality management and GMP at the University of StrathclydeMy specialties are defining quality systems at a global level; in particular, Quality Risk Management, Good Control Laboratory Practice, inc. OOS results and data integrity, Statistical Process Control and pharmaceutical law as it relates to product quality. I regularly speak in these subjects at both private company meetings and at public meetings organised by groups such as the PQG, PharMIG, PDA, ISPE, etc. as well as on the training course run by NSF.