FDA's Latest Regulations for Tobacco Industry Effective 8/2016

Carolyn Troiano is Keynote Speaker at ComplianceKey.She has more than 30 years of experience during which she worked directly, or as a consultant, for many top-tier pharmaceutical, medical device and biological companies in the US and Europe. She was responsible for computer system validation compliance activities across all GxP functions at a major pharmaceutical company. She developed computer system validation programs and strategies and was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. Carolyn has participated in industry conf........


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 (waterpipe) 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 should you attend this webinar?

You should attend this seminar 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 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.

Areas Covered in the Session:

Who can Benefit:

Within tobacco, e-cigarette, cigar, vapor and related manufacturing companies, people in the following roles will benefit from this presentation:

  • Manufacturing Analysts and Supervisors
  • Marketing Analysts and Managers
  • Information Technology Professionals
  • QC/QA Analysts and Managers
  • Laboratory Analysts and Managers
  • Compliance and Audit Managers
  • Automation Analysts and Managers
  • GMP Training Specialists
  • Computer System Validation Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Warehouse Managers
In addition, retailers of tobacco products should attend to gain expertise about the current regulations and those about to go into effect on August 8, 2016.
Anyone who is involved in the distribution of product must understand and conform to the Customs-Trade Partnership Against Terrorism (C-TPAT), which should part of the overall compliance program. We will touch on this subject during the webinar.
Finally, anyone who is acting as a consultant or contractor to a company in the tobacco industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment.

Webinar Id: LSHCCT006

Training Options:

Duration: 90 mins

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 $167 (Single Attendee)  $599 (Unlimited Attendee)

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