Lance Smallshaw

Background

About Lance Smallshaw

UCB World Pharmacopoeias Leader and Global Quality / Analytical Expert - Regulatory Intelligence Network, Knowledge and Analytical Program - Industrialisation and Network Planning 2. 44 Years experience in GMP/cGMP in Good Quality Control Laboratory Practice, Stability and QA in Pharmaceutical, Biopharmaceutical Analysis and the Development NBEs /NCEs of APIs and their Drug Products including Products of Fermentation. Currently Co-Chair of the European Compliance Academy (ECA) Executive Board from 1st Jan. 2018 (promoted from the previous honorary post of ECA Executive Board Director of Regulatory Affairs 2013). Incoming Chairman. REFER to VIDEO: Chairman of the Medicinal Cannabis Working Group of the ECA Academy. Past member and Associate Director of the and the European CMC Strategy Organizing Committee and worldwide member since 1995 5. Currently Member of the European QP Association Training Team in Good QC Laboratories Practices/Current Quality Topics for the past 10 years 6. Specific experience and more than 15 years training in statistical process control (SPC) and delivering training in applying, monitoring, control charting and best practices of charting applications Control and Capability ICHQ10. Past European Regulatory Variation Expert Report Writer. Expertise in Method Validation and Method Transfer. Compendial Expertise (Ph Eur/USP/JP) and UCB Primary Liaison to the EDQM and BP. QC Laboratory Worldwide Auditing Experience. Primary Contact for International Regulatory Audits - Labs. Past Expertise in Many UK Government/Industry - BIS (nee dti/DIUS) Funded New BioPharma Technology Initiatives qPCR, Host Cell Protein by MS, National Proteomics Project. International Speaker Experience with both UK MHRA, US FDA and other European Regulators. Company Lead for Elemental/Metallic Impurities, EP/USP/ICHQ3D and original member of the Lhasa Excips. Elemental Impurities Database Consortium. Setting Specifications for release and stability shelf-life. Member of the Efpia N-Nitrosamines /ICH M7 working group. Efpia MQEG CMC Pharmacopeial Working Group 20. Past UCB Lifecycle Management Team aQbD and Specs. Member of the Bio IQ Consortium AQbD. Specialties: Analytical Analysis, CAPA, Statistical Process Control (SPC), Pharmcopoeias, ICH, Lab.