FDA`s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016 2017

  • 07-08 Dec 2017
  • DoubleTree by Hilton Hotel San Diego Downtown, CA, United States

Description

Topics
  • Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
  • FDA Tobacco Control Act
  • PMTAs and Requirements
  • Details of the August 8, 2016 FDA Regulation
  • Minimizing Cost while Maximizing Compliance
  • How to Build a Compliance Strategy
  • Knowing the policies and procedures that must be developed and maintained to support the clinical trial system in operation
  • Industry Best Practices
  • Knowing about FDA trends in oversight and audit and how to keep abreast of these
  • Understanding how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system
Who should Attend
  • 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

Past Events

Important

Please, check "FDA`s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Industry: Tobacco

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