Robert Tomaselli RPT Medical Products Consulting, Inc.

Bob has over 33 years Quality Assurance and Process Development experience in the Medical Device and Diagnostics, Biotechnology, and Pharmaceutical (small and large molecule) industries. Bob took early retirement from J&J in 2013 and started an independent consulting business – RPT Medical Products Consulting Inc. In his previous position as Senior Director of Aseptic Processing at J&J Sterility Assurance, Bob influenced the company's strategic and tactical directions through the application of technical knowledge and expertise in aseptic processing and related Quality Systems for pharmaceutical, biological and combination products. He facilitated complex design and risk analyses and provides input or approval for facility, large equipment and process design specifications, qualifications, validations and control programs. He oversaw aseptic process development and optimization initiatives across J&J and directed activities in support of projects for novel sterile products. Bob has assisted in readiness reviews in advance of regulatory agency inspections, as well as responding to regulatory citations and other enforcement actions. He served as technical lead in due diligence and on-site assessments. He was an advocate for the implementation of innovative quality risk management and QbD programs. He continues to represent J&J at key industry standards organizations where he influences regulations and standards; most notably, he is the co-chair the U.S. Sub-TAG for ISO / TC 198 WG, Aseptic Processing of Health care Products. Bob has delivered world class training and sets the curriculum for aseptic processing training globally.

Prior to working for SPT, Bob was Director of Quality Affairs for Veridex, a J&J molecular diagnostics company, where he was responsible for establishing the Quality Management System. Before Veridex, Bob was Director of Quality Assurance and Regulatory Affairs at Orchid BioSciences, a biotechnology company; Director of Quality Assurance at ConvaTec, a Bristol-Myers Squibb medical device and combination products company; Manager of the Corporate QA Audit Program at Becton Dickinson Inc.; Senior Microbiologist at Hoechst-Roussel Pharmaceuticals; and began his career as Site Microbiologist for ConvaTec, E.R. Squibb & Sons. He has extensive experience in product/process development and validation, establishing quality management systems, GXP auditing, aseptic processing and terminal sterilization, clean room design, quality risk management, world class training, and project management.