George Serafin

George Serafin

Company: FTI Consulting

Job title: Life Science Industry Leader

Bio:

George Serafin is a Senior Managing Director at FTI Consulting. He is a member of the Health Solutions practice and is based in New York. Mr. Serafin serves as the life sciences industry leader responsible for the integrated delivery of services and solutions focused on assisting life sciences clients with solving their most complex problems and achieving their strategic and operational objectives. Mr. Serafin has 30+ years of experience in the areas of R&D, engineering, manufacturing, supply chain, quality control/laboratory, quality assurance, regulatory, compliance, corporate/operations, and information technology across pharmaceutical, biotechnology, medical technology, and consumer healthcare. Mr. Serafin has demonstrated domestic and international regulatory compliance experience including ANVISA, CMS, DEA, EMA, FDA, GCP/PV, GxP, HC, ICH, ISO, MHLW, MHRA, NMPA, PDMA, and PIC/S including product submission/approvals, site registrations, 483/Warning Letter/Consent Decree, response and remediation program development and execution. He is internationally recognized for his subject matter knowledge and experience concerning regulatory, quality, compliance, and risk management. Mr. Serafin is a strategic advisor to the FDA having assisted them in various areas including product quality, data integrity, cloud computing, and digital health.

Seminars:

Ask the experts: Morning Q&A + Open Counsel 10:20 am

Let the speakers answer the questions from the audience in this open counsel.Read more

day: Day One

Interactive Panel Discussion: How Can Industry Shape the Standards for Cloud Solutions in GxP-Regulated Environments? 1:45 pm

How have international regulatory standards, and the subsequent interpretation of these guidelines helped or hindered the pharmaceutical industry through transitions onto cloud platforms? What should be the roles and responsibilities of cloud service users and cloud service providers? Which resources should life science companies refer to to maintain data compliance and remain inspection ready?Read more

day: Day One

Regulatory Risk & Data Integrity Considerations for Cloud Computing & Managed Services 10:00 am

Clarity concerning roles and responsibilities between manufacturer and cloud vendor addressing GxP and Part 11 Compliance Agile software development lifecycle and the “least burdensome approach” to satisfy computerized system validation requirements Governance, monitoring, and oversight that should be considered for critical business or sensitive dataRead more

day: Day One

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