FDA Regulations for Tobacco & Tobacco-Related Products – Computer System Validation (CSV), 21 CFR Part 11 (electronic records/signatures), Data Integrity & Compliance

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.

Description:

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

We’ll discuss the Tobacco Control Act (2009) and the Deeming Rule (2016). We’ll also cover the new draft requirements for the Premarket Tobacco Application (PMTA) based on the Tobacco Product Manufacturing Practices (TPMPs), the draft of which was issued by FDA in early 2023.

We will cover GAMP®5, 2nd Edition, and how it aligns with CSA, providing a set of industry best practices based on critical thinking and following a risk-based approach. We will discuss non-linear forms of software development, testing and release, such as the agile methodology.

You will also learn about pending and potential regulations and where the tobacco and related product industries are heading in terms of compliance requirements.

Why Should You Attend:

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

In particular, if you are responsible for systems and data (structured and unstructured) supporting FDA-regulated operations, you will benefit by understanding how to meet compliance through validation and maintenance of a system in a validated state. You will also learn about electronic record and electronic signature compliance requirements, and the importance of maintaining data integrity.

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

Areas Covered in the Webinar:

• Tobacco Legislation (FDA)
• GxP Predicate Rules
• Tobacco Control Act of 2009
• Deeming Rule of 2016
• Proposed TPMPs (2023 Draft)
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC)
• Computer Software Assurance (CSA)
• Waterfall (linear) vs. Agile (non-linear) methodology for software development, testing and release
• Critical Thinking
• Risk-based approach to validation
• GAMP®5, 2nd Edition approach to system categorization and validation
• Implementation and validation of systems in compliance with FDA
• Roles, responsibilities and training
• Documentation required for FDA compliance
• Maintaining a system in a validated state
• Electronic Records and Electronic Signatures (ER/ES) compliance (21 CFR Part 11)
• Data Integrity (ALCOA+ Principles)
• Ratio of system cost to compliance with FDA
• SOPs required for supporting a validated system
• FDA Trends in Compliance and Enforcement
• Industry Best Practices
• Q&A

Who Will Benefit:

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.), but the content is also applicable to validation performed on computer systems in the pharmaceutical, medical device, & biologics industries. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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