Dr. Spanogle offers more than 25 years of technical, quality, compliance, and process/operations experience in the R&D, CSV, Clinical Supplies and Commercial GxP Manufacturing areas. He has relevant experience with Science and Risk Based Product and Process Design, Development of Clinical and Pre-Launch Product into Transfer to Commercialization. He is experienced in production and process problem analysis; Facility, systems and equipment start-up and C&Q; Sterilization and Aseptic Processing, Packaging, Test Methods & Automated Process Validations; Product Submissions; Proactive Regulatory Compliance Assessments. He is well versed in Root Cause Analyses, Remediation, and Implementation of remediation of findings. His R&D and Operations Compliance expertise encompasses the full gamut of expected elements of any GxP Quality System design and implementation or streamlining. Dr. Spanogle has also developed, conducted, and trained clients on numerous programs pertaining to Science and Risk Based Assessment/Root Cause Analyses; Design Space; QbD; Design Controls; CSV; CAPA; CD Resolutions; SOP Systems; Validation; EM & Cleaning Programs; Instrument/Equipment/Systems Validation; Test Method Qualification; and all other elements of GxP Quality Systems. His experience encompasses Pharmaceuticals, Medical Devices, Biotechnology, Combination Products, Aseptic/Sterile, OSD, and specialty dosage forms. Dr. Spanogle holds a Ph.D.in Genetic Engineering with minors in Statistics and Computer Science from Kansas State University; a MS in the same disciplines from Utah State University; a BS cum laude from Colorado State University in Wildlife Biology; is a FDA Certified HACCP (Risk Mgt) Facilitator and Trainer; Accomplished ASQ CQE and Certified-Software QE; Science and Risk Based Root Cause Assessments, Analyses and Problem Solver SME for Product/Process and Quality Systems Issues and Remediation; accomplished CSV SME: QbD & Design Control Submissions and Raw Data Integrity SME; Member American Society of Quality; and International Society for Pharmaceutical Engineers (ISPE) Member and Guide Books 1 & 2 Contributing Author.