FDA New Tobacco Rule and Recent Actions

Live Webinar

  • 60 minutes

The Tobacco Control Act went into effect by the 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.

Join this session by expert speaker Carolyn Troiano, where she 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:

  • 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 also focus on some of the recent trends in FDA inspection and compliance for all regulated industries, including tobacco and tobacco-related companies.

  • Finally, we will touch on Customs and Trade Partnership Against Terrorism (C-TPAT), highlighting key areas to focus on to ensure supply chain security is established and maintained.

  • 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.

Why You Should Attend:

You should attend this webinar if you work in the tobacco industry and are responsible for manufacturing, marketing, distribution or other functions that are now, or soon will be, regulated by the FDA. You should attend if you work for a tobacco company in the manufacturing, marketing, or distribution areas. You should also attend if you are a retailer or own a vapor shop. An effective and compliant strategy is critical to any FDA-regulated organization, including those in the tobacco industry. Knowing the regulations is the first step toward ensuring compliance, and learning about industry best practices is a sure way to learn how to balance compliance with cost.

Who Should Attend:

  • Information Technology Analysts

  • QC/QA Managers

  • QC/QA Analysts

  • Analytical Chemists

  • Compliance Managers

  • Laboratory Managers

  • Automation Analysts

  • Manufacturing Managers

  • Manufacturing Supervisors

  • Supply Chain Specialists

  • Computer System Validation Specialists

  • GMP Training Specialists

  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance, and audit

  • Consultants working in the tobacco and tobacco-related industries who are involved in computer system implementation, validation and compliance

  • Auditors engaged in the internal inspection of operational practices

  • Vendors of computer systems and software used in the tobacco and tobacco-related industries

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Carolyn  Troiano

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).

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