FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016

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

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