Mark Spinelli

Background

About Mark Spinelli

Over the last 34 plus years I've gain experience and worked in roles with increasing responsibility. I’ve developed, implemented and managed Metrology, Validation, and Preventative Maintenance programs with as many as 35 direct reports, managed multi-million-dollar projects, and worked closely with Quality and Regulatory on submissions. I attend regulatory inspections with US FDA, Health Canada, and Europe (EU, Irish Medical Board, and UK). I understand cGMP and cGLP requirements and am familiar with PDA, USP, ICH, and HTM2010 guidance documents, and CFRs 210, 211, and Part 11. I work in countries outside the United States including Denmark, Sweden, Switzerland, Germany, and most recently Canada. I've managed aseptic barrier technology manufacturing facilities, developed and validated Parametric Release programs for terminally sterilized injectable products, and have experience with Controlled Substances and Potent Compounds. I have a US Patent Pending, 35800-22 (H-MI-00389) Fully Sealed, Terminally Sterilized Radionuclide Generator Column Assembly and Methods of producing same. I’m a Subject Matter Expert (SME) in aseptic and terminally sterilized manufacturing.