Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. Siegfried received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry. Dr. Schmitt is an active member of various industry associations, including DIA, PDA and ISPE, conference presenter and organiser of international events. He is also an accomplished author and editor, having won the coveted ‘distinguished PDA author / editor award’ in 2008 and 2012. Dr Schmitt is a Chemist by background and holds Chartered Chemist and Chartered Scientist status.