FDA`s Latest Regulations for Computer Systems Used in the Tobacco 2017

Topics

• Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
• FDA Tobacco Control Act
• Pre-Marketing Tobacco Application (PMTA) Submission
• Details of the August 8, 2016 FDA "Deeming" Regulation
• Computer System Validation (CSV) and the System Development Life Cycle Methodology (SDLC)
• FDA Oversight and Compliance Strategy
• Policies and Procedures
• Cost vs. Compliance
• Industry Best Practices
• Leveraging Vendors
• FDA Trends