Senior Quality Assurance Chemist
Evan T. Ogburn is Senior Quality Assurance Scientist at Vitale Scientific Associates, LLC (VSA) and is certified by the USA Society for Quality (ASQ) in pharmaceutical current Good Manufacturing Practices (cGMP) and quality systems auditing. He has years of hands-on, professional experience in project management, laboratory operations, quality assurance and experimental design for the characterization and quantitation of ionic and nonionic organic compounds in cGMP and Good Laboratory Practices (GLP) regulated environments. Mr. Ogburn is an expert in analytical method development and validation in accordance with International Conference on Harmonization (ICH) and United States Pharmacopeia (USP) guidelines for HPLC-MS, HPLC-MS/MS, CAD, IC and other analytical techniques. He has performed and supervised these methodologies on a variety of projects, throughout all phases of the Investigational New Drug (IND), New Drug Application (NDA), and post-market evaluation phases (i.e. Phase 0 – Phase 4). These studies included chemical and physical property determination, long and short term stability, kinetic solubility, pharmacokinetics and pharmacodynamics testing at advanced performance levels in the development and characterization of active pharmaceutical ingredients, drug products, drug delivery systems, process impurities and degradation products.
Mr. Ogburn is a contributor and project manager in VSA’s work assisting the Massachusetts Department of Public Health (MDPH) in refining and implementing their laboratory examination program, conducting audits, or laboratory examinations to evaluate laboratory compliance, and providing a Quality Assurance Program Plan[DT1] and supporting technical procedures for the laboratory analysis of medical cannabis and cannabis products. He has also drafted technical specifications manuals (TSMs) defining technical and QA contractual obligations for third-party laboratories, and narrative sections of cannabis cultivation and laboratory processing permit applications. Mr. Ogburn has experience implementing Quality by Design (QbD) and process analytical methodologies to enhance the understanding and control of manufacturing processes from raw materials through final product development and packaging. This includes using knowledge of technical requirements and quality assurance and quality control (QA/QC) principles in order to develop sampling and analysis plans and the sampling and analytical method validation and testing protocols needed to ensure acceptable and reproducible product quality throughout a product’s life-cycle.
In addition to his work in the cannabis industry, he provides technical guidance and quality assurance support across several manufacturing industries through the development and implementation of quality systems under the requirements of ISO9001:2015 and ISO/IEC 17025:2005 international standards.
Mr. Ogburn earned a B.A. in Chemistry from Earlham College and an M.S. in Analytical Chemistry from the University of Cincinnati.