Tobacco Industry Trends for Computer Systems Regulated by FDA

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

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.

Objectives of the Presentation:

• 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

Areas Covered in the Session : 

• 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
• Interactive Q&A Session

Who Should Attend:

Mainly, this is for companies in the tobacco, cigar, e-cigarette, e-liquid/vaping industries, but all FDA-regulated industries would also benefit:

• Pharmaceuticals
• Biologicals
• Medical Devices
• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• 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

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, 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. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.