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
Agenda
This webinar 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
Who Should Attend
- Professionals in the following industries may also benefit from the content:
- Pharmaceutical
- Medical Device
- Biotechnology
- Tobacco and Related (Vapor, e-Cigarette, Cigar, etc. )
- Any other FDA-regulated industry
- plus any Life Science Consulting or Contracting firm
- Information technology managers and analysts
- QC/QA managers and analysts
- Clinical data managers and scientists
- Compliance managers
- Lab managers and staff
- Automation analysts
- Computer system validation specialists
- GMP training specialists
- Business stakeholders and individuals who are responsible for computer system validation planning
- execution
- reporting
- compliance
- and audit
- Consultants working in the life sciences
- tobacco and related industries who are involved in computer system implementation
- validation and compliance
- Anyone involved in the planning
- execution and reporting of a clinical trial (sponsor, director, researcher, regulatory role, etc. )
