Tobacco Industry Trends for Computer Systems Regulated by FDA
Carolyn Troiano has more than 35 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.
The Tobacco Control Act went into effect by the 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
We will provide 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.
We will discuss the importance of applying industry best practices when validating systems and applications used in the tobacco industry, as regulated by the FDA. This includes system development, configuration, implementation, testing, validation, and other System Development Life Cycle (SDLC) phases for any IT system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
With the Tobacco Control Act of 2009 and the Deeming Rule of 2016, the Tobacco and related industries understand they will be subject to guidelines from FDA similar to those imposed on other FDA-regulated industries. This course will describe the best practices for validating such a system, including “who" should be responsible for tasks, "how" the documentation should be accomplished, and “what” specific criteria will be used to define success. FDA guidelines are very specific in terms of how this is to be done.
We will also cover other aspects of FDA computer system validation, including GAMP 5 System Classification, Risk Management, 21 CFR Part 11 (electronic records/signatures) and the System Development Life Cycle (SDLC) Methodology. We will also cover FDA inspection trends and, in particular, the importance of assuring data integrity is maintained throughout its life cycle. We will discuss industry best practices to counter these issues.
- Tobacco Legislation (FDA)
- GxP Predicate Rules
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC)
- A risk-based approach to validation
- GAMP V 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
- Data Integrity
- The ratio of system cost to compliance with FDA
- SOPs required for supporting a validated system
- Industry Best Practices
Who Should Attend
Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:
- Medical Device
- 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
Personnel in the following roles will benefit
- 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