• FDA Compliance and System Validation for Tobacco and Related Products
  • FDA Compliance and System Validation for Tobacco and Related Products

    • Speaker : Carolyn Troiano
    • Session Code : CTJUL3123
    • Date : 31st July 2023
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 90 Mins


In this webinar, We will explore the significance of applying industry-best practices during the validation of systems and applications used in the tobacco industry, as regulated by the FDA. This includes all stages of the System Development Life Cycle (SDLC) such as system development, configuration, implementation, testing, validation, and documentation, for any IT system employed in an FDA-regulated environment (i.e., the system 'interacts' with the product during manufacturing, testing, or distribution). These systems must be validated following FDA guidelines for computerized systems.

The FDA initiated the Tobacco Control Act on June 22, 2009, regulating cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. In 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, extending the FDA’s authority to regulate 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 rule came into effect on August 8, 2016.

This milestone in consumer protection enables the FDA to:

  • Review new tobacco products not yet on the market
  • Prevent misleading claims by tobacco product manufacturers
  • Evaluate the ingredients and manufacturing process of tobacco products
  • Communicate the potential risks of tobacco products

In March 2023, the FDA issued a draft guidance covering the proposed Requirements for Tobacco Product Manufacturing Practice (TPMP). These guidelines are intended for both finished and bulk tobacco product manufacturers, aiming to establish requirements for manufacturing, preproduction design validation, packing, and storage. The proposed requirements ensure that tobacco products comply with chapter IX of the FD&C Act.

We will examine the most recent draft guidance documents from the FDA and the EU, focusing particularly on the systems employed in the design, manufacturing, quality assurance, distribution, and marketing of tobacco and related products.

This webinar provides an overview of the regulations applicable to the manufacturing, marketing, distribution, and other operational activities of companies in the tobacco industry.

With the implementation of the Tobacco Control Act of 2009 and the Deeming Rule of 2016, the Tobacco and related industries are now under FDA guidelines similar to those imposed on other FDA-regulated industries. The proposed TPMPs will offer further guidance on achieving FDA compliance.

This course will clarify GxP systems and the validation process according to FDA requirements, including responsibility distribution, documentation processes, and specific success criteria. FDA guidelines are explicit in how these processes should be executed.

Further, we will discuss other aspects of FDA computer system validation, including GAMP®5 System Categorization, Risk Management, 21 CFR Part 11 (electronic records/signatures) and the System Development Life Cycle (SDLC) Methodology.

Lastly, we will discuss FDA inspection trends and emphasize the importance of maintaining data integrity throughout its life cycle. We will review industry best practices for addressing these issues."

Areas covered during the session include:

  • 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)
  • Risk-based approach to validation
  • GAMP®5 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
  • 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

Why Should You Attend:

The regulatory landscape for tobacco and related products is continually evolving, presenting new challenges for companies operating in these sectors. By attending this webinar, you'll gain insights into the latest FDA regulations and guidance, learn how to apply best practices for system validation, and understand the importance of maintaining data integrity.

Our expert will decode the Requirements for Tobacco Product Manufacturing Practice (TPMP) and explain their implications for both finished and bulk tobacco product manufacturers. You'll learn how to comply with these requirements and avoid potential pitfalls.

The lessons learned from this webinar can help ensure that your IT systems are FDA-compliant, thereby avoiding costly regulatory missteps. Whether you're developing, implementing, or managing systems that interact with tobacco products, this webinar will equip you with the knowledge and strategies you need to succeed in a highly regulated environment.

What industries will benefit from this training?

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs and proposed TPMPs:

  • Tobacco (based on the Tobacco Control Act of 2009)
  • E-Liquid/Vapor (based on the “Deeming” Act of 2016)
  • E-Cigarette (based on the “Deeming” Act of 2016)
  • Cigar (based on the “Deeming” Act of 2016)
  • Third-Party companies that support those in the above industries
  • Software product and service providers targeting companies in the FDA-regulated industries

Who Should Attend:

This webinar is designed for professionals involved in the design, manufacturing, quality assurance, distribution, and marketing of tobacco and related products.

More specifically, this webinar will be invaluable for:

  • Quality Assurance Managers
  • Regulatory Affairs Professionals
  • IT Professionals in the Tobacco Industry
  • Compliance Officers
  • Product Development Managers
  • Business Analysts

Whether you're directly involved in system validation or are a decision-maker looking for a broader understanding of the regulatory landscape, this webinar can provide essential guidance and insights. If you're working to navigate the complexities of FDA regulations and keep your company's systems compliant, don't miss this opportunity to learn from the industry expert.

Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, 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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Tags: "FDA Compliance", "Tobacco Industry", "Computer System Validation", "Regulatory Webinar", "21 CFR Part 11", "Data Integrity", "GxP", "TPMP", Webinar, Carolyn Troiano, July 2023