Online Seminar 2019 - Trends in FDA Compliance for Regulated Computer Systems in the Tobacco Industry

Overview
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.
Session Highlights
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 will benefit
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.)
SPEAKER:
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.