George Toscano

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.

Experience

1. President

   Toscano Consulting Group

   Mar 2019 — Present · Miami, TX, US

   TCG provides quality and regulatory consulting services to the Pharmaceutical, Biologics and Medical Device Industries. Our services Include Auditing, Gap Assessments, Regulatory strategy and submission support, due diligence support and response to FDA enforcement actions including: 483s, Warning Letters, Consent Decrees (permanent injunctions), AIP (Application Integrity Policy), Expert Witness for litigation support, Import Alerts, and Product Seizures.

Education

• University of Central Florida

  Bachelor of Science - BS, Biology

  1993 — 1997

• Florida Atlantic University

  MBA, International Business

  2003 — 2005

• Pace

  High School/Secondary Diplomas and Certificates

Skills

• Product Development
• Technology Transfer
• Analysis
• Regulatory Submissions
• CRO
• Commercialization
• Laboratory
• Drug Development
• Gcp
• Biopharmaceuticals
• Biotechnology
• Quality Management
• Strategy
• Regulatory Affairs
• Lifesciences
• Iso 13485
• Regulatory Requirements
• Pharmaceutical Industry
• Sop
• Fda
• Glp
• Validation
• Crm
• 21 Cfr Part 11
• Quality System
• V&V
• Process Simulation
• Vaccines
• Software Documentation
• Root Cause Analysis
• Computer System Validation
• Manufacturing
• Pharmaceutics
• Gxp
• Quality Auditing
• Cross-Functional Team Leadership
• Competitive Intelligence
• Quality Assurance
• Clinical Trials
• Medical Devices