George Toscano has been appointed senior director of Quality Systems, Pharmaceuticals, Biotech and Biologics at NSF International. Mr. Toscano has more than 16 years of experience helping companies in the global pharmaceutical, biologic and biotechnology markets develop and execute quality systems solutions. He reports to Maxine Fritz, executive vice president of Pharmaceuticals and Biologics at Becker & Associates Consulting, part of NSF International's Health Sciences Division.
Mr. Toscano will assist companies in the pharma and biopharma industries, both foreign and domestic, in developing compliant quality and regulatory strategies. His primary area of focus includes NDA and ANDA review sections covering production and batch records, stability data, validation data, qualification records, supplements, amendments, and bio-equivalence studies. He also specializes in conducting GMP and GLP assessments of facilities to support regulatory applications to the FDA.
Mr. Toscano's technical background and broad range of experience includes validation, vendor qualification, auditing, batch record review, product release and stability, investigation of non-conformances, and cGMP and GLP training. He has provided counsel on lab and manufacturing investigations, CAPA development and implementation, training, stability programs and other quality systems. He also has served as project lead and expert consultant on compliance initiatives involving corporate 483 responses, warning letters, consent decrees and application integrity policies.
"George's extensive experience in quality systems will play an integral role in assisting companies to develop and implement quality solutions that will help expand their operations while safeguarding their reputation," said Bob Pietrowski, vice president of Health Sciences for NSF International.