George Toscano Appointed Senior Director, Quality Systems, Pharma, Biotech and Biologics
ANN ARBOR, Mich. – NSF International, a global independent public health organization that writes standards, and tests and certifies products for the health sciences, consumer goods, food and water industries, has appointed George Toscano Senior Director of Quality Systems, Pharmaceuticals, Biotech and Biologics. Toscano has more than 16 years of experience helping companies in the global pharmaceutical, biologic and biotechnology markets develop and execute comprehensive quality systems solutions.
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 (good manufacturing practices) and GLP (good laboratory practices) training. He has provided hundreds of companies with expert counsel on laboratory and manufacturing investigations, CAPA (corrective and preventative action) development and implementation, training, stability programs and other quality systems. Toscano also has served as project lead and expert consultant on compliance initiatives involving corporate 483 responses, warning letters, consent decrees and application integrity policies (AIP)
As Senior Director of Quality Systems, Pharmaceuticals, Biotech and Biologics, Toscano will assist companies in the pharmaceutical, biologic and biotechnology industries, both foreign and domestic, in developing compliant quality and regulatory strategies. His primary area of focus includes NDA (new drug application) and ANDA (abbreviated new drug application) review sections covering production and batch records, stability data, validation data, qualification records, supplements, amendments, and bio-equivalence studies. Toscano also specializes in conducting GMP and GLP assessments of facilities to support regulatory applications to the U.S. Food and Drug Administration (FDA). He will report to Maxine Fritz, Executive Vice President of Pharmaceuticals and Biologics at Becker & Associates Consulting, part of NSF International's Health Sciences Division.
"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.
Toscano has previously served as the Director of Quality Control and R&D for pharmaceutical and biotechnology companies, and has coordinated analytical activities and method development processes and procedures in accordance with FDA and other regulatory agency requirements. Toscano has an MBA from Florida Atlantic University and a Bachelor of Science degree from the University of Central Florida.
NSF representatives will speak at the Parental Drug Association (PDA)/FDA Joint Regulatory Conference September 16-18, 2013 in Washington, D.C. on global regulatory issues including excipient GMPs, pharmacopoeias and the international harmonization of monographs.
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About NSF International's Health Sciences Division: Operating globally throughout North America, Europe, the Middle East, Asia and Latin America, the NSF Health Sciences Division offers training and education, consulting, auditing, GMP and GLP testing, GMP facility registration, product certification, R&D and regulatory guidance for the pharma, biotech, medical device and dietary supplement industries throughout the product lifecycle. NSF wrote the only accredited American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard. NSF also supplies pharmaceutical secondary reference standards, traceable to USP and EP standards.
NSF International offers ISO 13485 registrations for medical devices and CE marking delivered through NSF International Strategic Registrations, Ltd. (NSF-ISR), as well as drinking water filtration certification through the NSF Global Water Division. Additional services include safety audits for the food and water industries, environmental and sustainability services through NSF Sustainability and training courses through NSF Training and Education.