George Toscano

Background

About George Toscano

Mr. Toscano has served as project manager and expert consultant on large complex international compliance projects involving corporate 483 responses, Warning Letters, Consent Decree(s), and AIP. He has provided clients with expert counsel on laboratory and manufacturing investigations, CAPA development and implementation, change control, training, stability programs and other quality systems. He is a recognized Data Integrity expert and has been involved in numerous audits and assessment to evaluate companies systems. In addition, he has assisted companies with remediation activities related to Data Integrity deficiencies and enforcement actions.Mr. Toscano has managed analytical R&D laboratories and has extensive knowledge of product development, method development, validation and transfer. He has served as project lead for large scale international method transfer projects. Mr. Toscano has managed or overseen product development and the generation of CMC sections for regulatory submissions of ANDA's, NDA's and 505(b)2 applications. Most recently he was project lead for a multi-year facility expansion and remediation project for a major Biologics manufacturer under consent decree with a successful outcome for the client.Mr. Toscano has over 25 years of industry experience working in quality assurance, data integrity, 21 CFR Part 11, validation, vendor qualification, auditing, batch record review, product release and stability, investigation of non-conformances, cGMP training, senior management and facility expansion. His technical background and broad range of experience has proven essential in providing clients strategies for the implementation and remediation of quality systems to comply with FDA regulations.