Tobacco Industry Trends for Computer Systems Regulated by FDA



We will discuss the importance of applying industry best practices when validating systems and applications used in the tobacco industry, as regulated by 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.

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.

Areas to be Covered:

Tobacco Legislation (FDA)
GxP Predicate Rules
Computer System Validation (CSV)
System Development Life Cycle (SDLC)
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
Ratio of system cost to compliance with FDA
SOPs required for supporting a validated system
Industry Best Practices

Who will Benefit:

This webinar is intended for those working in the tobacco and other FDA-regulated industries, including pharmaceutical, medical device, biological, and animal health. 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. Examples of who will benefit from this webinar include:

Information Technology Analysts
Information Technology Developers and Testers
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Compliance and Audit Managers
Laboratory Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders/Subject Matter Experts
Business System/Application Testers
Consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.

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.


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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance