FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

OVERVIEW

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

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 FDA tobacco regulation 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 that discusses FDA deeming regulation is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

AREAS COVERED

Topics covered include:

• 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
• Compliance Strategy
• Cost vs. Compliance
• Computer System Validation (CSV)
• Industry Best Practices
• Policies and Procedures
• Leveraging Vendors
• FDA Trends
• Best Practices

LEARNING OBJECTIVES

• FDA Tobacco Control Act and “Deeming Rule”
• Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
• Details of the August 8, 2016 FDA Tobacco Regulation
• PMTAs and Requirements
• How to Build a Compliance Strategy
• Minimizing Cost while Maximizing Compliance
• Industry Best Practices 
• Know the policies and procedures that must be developed and maintained to support the clinical trial system in operation
• Understand 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
• Know about FDA trends in oversight and audit and how to keep abreast of these

WHO WILL BENEFIT

Industries:

• Tobacco
• e-cigarettes
• e-liquids (vapors)
• Cigars
• Smokeless/Pouch Tobacco

Positions:

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Quality Managers, Chemists and Microbiologists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above

This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

For more detail please click on this below link:

https://bit.ly/2RKJh39

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