Bill Spanogle, PhD, MS

Sr Director of Product & Process Development

Bill is a highly accomplished, adaptable C-Level Advisor and hands-on leader in the full spectrum of Regulated Life Sciences Product & Process Development, RA/QA, EU-MDR/IVDR, QbD, and CSV-GAMP-Part11. Bill has  successfully characterized and taken scores of medical devices, Biotech, Pharma, and Combo Products, Designs, Materials, & Processes from concept through commercialization via QbD, Design Controls, Risk, PMS, CER, PRRC, data trending, submissions, site inspections, turnarounds, and all intermediate functions. He is a recognized international & domestic invitational Biotech, medical device, Combo, CSV, and regulated life science leader, presenter, assessor, remediator, instructor, implementor, and author. Those who have and do work with Bill, continually nickname him “Doctor Bill” for his passion, skills, integrity, and compassion in effectively aligning and harmonizing people and organizations within the regulated life science Industry. Bill’s Regulated Life Sciences background includes, but not limited to, Management, Leadership, and Director Levels for J&J Medical Devices, Biotech, Stem Cells, IVDs; turnaround of Carefusion, and IVD Submissions Serono-Baker, respectively. These experiences span several decades, multiple continents, numerous International Regulatory Bodies. His Medical Device Design Control expertise has its roots in my nearly five years of Software Design and Development and Controls. To-date Bill has led and guided >4000 professionals, across multiple global Sites, in Design Controls, CSV, Part 11 GAMP & QbD, and 1000s of professionals as an Invitational Presenter at numerous Professional Conferences, and 1000s more via publications and ISPE Guide Series.