Get 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.
The Tobacco Control Act by FDA went into effect 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.
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
Learning Objectives:
- Learn about the Tobacco Control Act and the "Deeming" rule
- Understand the importance of Computer System Validation (CSV) and maintaining a system in a validated state
- Learn about FDA inspection readiness
- Understand the importance of data and system governance
- Understand the System Development Life Cycle (SDLC) methodology and how it supports CSV
- Know how to comply with 21 CFR Part 11, the FDA's guidance on electronic records and signatures
- Learn which policies and procedures are necessary to support your validated system
- Understand the importance of training for validation, system use and system support
Why Should You Attend:
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.
This webinar 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
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
- 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
- Q&A
Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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.