William Spanogle

Background

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 13485-16 & 14971-2019, 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