Dr. Michael Ruberto is the President of Material Needs Consulting, LLC which provides consulting services to manage the development and commercialization of medical devices and packaging, with a special emphasis on material selection, extractables and leachables, and supply chain management.  He has been an active member of various pharmaceutical working groups that have developed “best practices” for characterizing and evaluating the safety of container closure systems and packaging for several different drug dosage forms.  Some of these teams include:

• PQRI Orally Inhaled and Nasal Drug Product E&L Working Group
• PQRI Parenteral and Ophthalmic Drug Product E&L Working Group
• United States Pharmacopeia (USP) Packaging and Storage Expert Committee 

Dr. Ruberto was formerly the Head of Regulatory Services for the NAFTA region at Ciba Specialty Chemicals where he was responsible for world wide notifications of new products, food contact notifications, and regulatory compliance of Ciba chemicals.  He also designed leachable and extractable studies for the FDA approval of medical devices, packaging, and labels used on drug containers.  Dr. Ruberto was previously the Director of Analytical Research, where he led a full service analytical laboratory that specialized in performing testing associated with the development and commercialization of new products including chemical characterization, migration studies, applications support, and technical service. Dr. Ruberto was employed by Ciba for fifteen years where he has performed numerous migration studies to support FDA and European Union indirect food contact notification for various additives, pigments, and polymers.  He was part of a team commissioned to establish a Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP) program in Ciba’s Analytical Research Department and served as GLP Study Director for many product characterization and Base Set studies needed for global product registration of novel additives.  Dr. Ruberto received a B.S. with thesis from Stevens Institute of Technology and a Ph.D. in Analytical Chemistry from Seton Hall University.