FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

Why Should You Attend:

FDA 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

An effective and compliant strategy is critical to any FDA-regulated organization, including those in the tobacco-related industries. 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.

You should attend this seminar if you work in the tobacco or related industries and are responsible for manufacturing, labeling, marketing, distribution or other functions that are now, or soon will be, regulated by FDA.

You should attend if you work for a tobacco or related product company in the manufacturing, quality, information technology, marketing, or distribution areas. You should also attend if you are a retailer or own a vaping shop.

Areas Covered in the Webinar:

• FDA Tobacco Control Act
• Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
• Details of the August 8, 2016 FDA Regulation (“Deeming Rule”)
• Recent Trends in Regulation and the Future of Tobacco and Related Industries
• PMTAs/MRTPAs
• E-liquids, ENDS and Vaping Devices
• Compliance Strategy
• Cost vs. Compliance
• Industry Best Practices
• Policies and Procedures
• Leveraging Vendors
• FDA Trends
• Best Practices
• Q&A

Free Materials:

During the webinar we will discuss FDA Guidance Documents and GAMP5, the Good Automated Manufacturing Practices. There will also be an overview of Policies and Procedures, including a checklist of topics

Who Will Benefit:

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• 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 life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in the internal inspection of labeling records and practices

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

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