William Spanogle

About William Spanogle

FDA and International expert across the full spectrum of Regulatory Life Sciences & scope of the Product Lifecycle. Proven expert: Pre-IND/BLA/QSub Mtg, CMC-Risk-QMM-Submissions-Registration bringing scores of Products/Processes from Discovery - Phase 4 EUAs, PIND, IND, NDAs, ANDA, 510(k), De Novo, NCE/NME, Combination Products, BLA, PAIs, etc. Proven Science-Risk-Data Driven Full Product Lifecycle Go-To leader, expert, and Invitational Author/Presenter/Mentor in QbD Characterization, BREXIT-UKCA Process, Design Controls, EU-MDR/IVDR 2017. Risk Mgt (2019) Benefit Analyses, CARES, CSA/CMMI, CSV, GAMP 5, RDI, Design & Tech Transfer, Data Integrity, eCTD- Module 1-5 CMC, 510(k), BLA, PAI, Clin Trials & Supplies, CER, GCP, GLP, FA-Complaints-PMS-Design Controls, & Digital Trans. As Sr Director at https://biotechresearchgroup.com/, Provide Product & Process Development Core Regulatory Affairs Services, Submissions, and US Agent/Interface with FDA, EU, UK, TGA, Canada, Japan, WHO, DOD, and all other International Regulatory Bodies. Proven go-to executive, adviser and leader for C-Suite & All-Levels via Hands-On Regulated Life Sciences Service and Deliverables. I adhere to, design, & implement Current USA & Global Life Science Regulations to bring scores of Biologics, Biotech, Stem-NK-T cells, GTx, Antagonists, Med Dev, OTC, Combo Products, Early Discovery, First In Humans, Clinical Trials, Scale Up, and Tech/Methods Transfer to Commercialization. • FDA & EU-MDR Submissions, eCTD Mod 1-5, 510(k), 21CFRs, ICHQ1-Q12, ISO 13•••16 & 14•••••19, MHRA-17, QMM. • ISPE PQLI QbD Invitational Author Guide 1 & 2 https://ispe.org/sites • SVMPs, RMPs & Remediation, LOAEL - NOAEL - ALCOA+ • Val - Qual Compliance Assessments, Audits, Resolutions • GO TO PROBLEM SOLVER & LEADER: mentoring relationships: Individuals, Teams, Groups, Companies: • CAPA, Investigations, Change Mgt, Control, Complaints, Data Integrity • CD Remediation, Submissions, CBE30, APRs • Six-Sigma, DMAIC, GAMP, CSV/CSA, RDI, IOPQ • Innovate-Compliant Breakthroughs • SOPs, MBRs, Test Methods (ALL ASPECTS) • IV, Needle Free, Transdermal Delivery, Troubleshooting • GMP, EU & QSR Operations, RA & QS Turnarounds • Aseptic-Sterilization Proc-Pack-Seal • SQM, SQA, PV, MSA, QTA • ISO 63204 Part 11, CSV/CfQ/CSA, GAMP • Multi-Prod\'t Facilities • 3rd Party Relationships • Containment, Cleaning, EM * ASQ-CQE #20186 * ASQ-CSQE #740 * ASQ-FDA Invited Spkr - GMP CSV/CfQ/CSA * FDA Certified HACCP FMEA Facilitator (ISO 14971)* ICH Q1-Q12, USP, PhEur * Certified Covey 7 Habits Facilitator & Principle Centered Leadership

Experience

1. Sr Director Product Development (Regulated Life Sciences)

   Biotech Research Group

   Oct 2020 — Present

   RA Agent, Write, Review, Submit-FDA & Global, Characterization (ICH Q1-12, QbD), 510(k), Predicates, CMC, eCopy, ESG, ESS, eCTD, IND, NDA, ANADA, INAD, JINAD, NADA, ANADA, CNADA, Supply Chain, Investigations & Root Cause, QMS, Inspection Readiness, & Full Spectrum of ALL related Regulated Life Sciences Products, Processes, and Regulations, PV, AR, PADER, MAH. • Med Dev, SaMD-AI, & Combo Prod\'t: Science-Risk Based RA Strategy & Rapid 510(k), Design Controls, GMPs, EU-MDR/IVDR 2017 & Infrastructure, Clinical Evaluation Plan & Report, Pre Market Requirements, Post Market Reqts (PMS, PMCF, Risk Management Product Life Cycle), 510(k) or De Novo Submissions, IDE, PMAs, Classification, Registration, listing, recalls, Import/Export, FDA Communications, 513(g) Request for Information, HUD/HDE Submissions • Pharmaceuticals (Rx, Tx, OTC): Science-Risk Based RA Strategy and Rapid CMC, FDA Briefing Package, Pre-IND Meeting, FDA communications and meetings Discovery through Phase IV, Clinical Trial Coordination & GCPs, QMS-GMPs, Pilot Plants, Scale Up, SVMP, CMOs, QTAs, Orphan Drugs, Literature & Scientific Research Reviews, 505(b)2, CBE-30 & 21CFR314, 513(g) Request for Information, ANDA suitability, Technical File Content, Review & CMC, Global Regulation Interpretation and Implementation • Biologics: Science-Risk Based RA Strategy and Rapid CMC, Pre-Clinical testing & verification, Clinical Trial Coordination & GCPs, Pharm/Tox, TQM-QMS, Biologics Manufacturing (Aseptic/Sterility), Pilot Plants, Scale Up, SVMP, Suppliers, CMOs, QTAs, GTPs, GMPs, GLPs, SOPs, BLAs and PMIs. • Quality & Compliance: QMS, CSA/CSV, Part 11, RDI, SOPs (Dev, red line, implementation, training), All GxP Training, Mock FDA Inspection & Readiness, Vendor Audits, Vendor Selection Assessments/Remediations, 483/WL/CD Remediation, SVMP, Clean Rooms & Sterility, Recalls, Adverse Event-Deviations-CAPA Root Cause ID & Remediation, FDA & Global Regulations QMS Regulations. • Regulatory Litigation Expertise.

Education

• Utah State University

  MS Degree, Plant Science: Genetic Eng, Comp Sci & Stats

• Colorado State University

  BS Degree, Wildlife Biology - Cum Laude

• Kansas State University

  Ph.D., Agronomy: Genetic Engineering, Comp Sci & Stats