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FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products
- FDA Tobacco Control Act
- Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
- 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
Overview of the webinar
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.
Who should attend?
- 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
Why should you attend?
FDA The Tobacco Control Act. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, 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
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.
Faculty - Ms.Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.