October 5th & 6th, 2017Time: 9:00 AM to 6:00 PM

Richmond, VAVenue: WILL BE ANNOUNCED SOON


Director : Carolyn Troiano
Course “FDA’s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (water pipe) tobacco, pipe tobacco and nicotine gels, among others. The rule went into effect on August 8, 2016.

This action is a milestone in consumer protection. Going forward, the FDA will be able to:

  • Review new tobacco products not yet on the market
  • Help prevent misleading claims by tobacco product manufacturers
  • Evaluate the ingredients of tobacco products and how they are made
  • Communicate the potential risks of tobacco products

We will provide an overview of the regulations as they pertain to the manufacturing, marketing, distribution and other operational activities engaged by companies in the tobacco industry.

This course will describe the best practices for developing a compliance strategy, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.


Why you should attend

This seminar will provide key information about the following areas:

  • FDA Tobacco Control Act
  • Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
  • Details of the August 8, 2016 FDA Regulation
  • PMTAs and Requirements
  • How to Build a Compliance Strategy
  • Minimizing Cost while Maximizing Compliance
  • Industry Best Practices
  • Knowing the policies and procedures that must be developed and maintained to support the clinical trial system in operation
  • 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
  • Knowing about FDA trends in oversight and audit and how to keep abreast of these

Areas Covered in the Session:

This course includes the following key areas of learning:

  • 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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