A computer system in an FDA regulated environment touches the product during the manufacturing, testing or distribution process and must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
With the bringing of tobacco products under the FDA regulatory jurisdiction in recent years, guidelines for validation of computer systems used in the manufacture, testing or tracking of tobacco-related products, including cigarettes, cigars, e-cigarettes and other forms of smokeless tobacco, such as “pouch” products, have come up. The guidelines follow the FDA’s requirements as set forth starting in the mid-1980’s for pharmaceutical products, and subsequently, for biotechnology-related products and medical devices.
Effective and compliant computer system validation is critical to any FDA-regulated organization, including those manufacturing, testing and distributing regulated products. During the past 30 years, best practices have been developed to ensure that the cost of building and managing a computer system validation program for this purpose, along with the necessary policies and procedures, will be minimized. FDA guidelines are very specific in terms of how this is to be done, and each company should have a specific strategy/methodology, and a set of very rigorous internal policies and procedures that prescribe how this will be planned, executed and documented.
In this session, expert speaker Carolyn Troiano will discuss the importance of applying industry best practices when performing the validation process. This session will focus on best practices for developing a strategy and conducting validation work, including roles and responsibilities, and the procedures that should be followed. Since there is an enormous body of documentation and information available that can be overwhelming, this session will provide a condensed overview of the practices that deliver the best results. It will do so by exploring the most critical and cost-effective of methods, techniques and tools available to assure a compliant validation process.
Those employees responsible for planning, executing or managing the validation of a system governed by FDA regulations, specifically in relation to pharmaceutical, medical device, biologicals, tobacco and related products, including cigarettes, and more recently developed e-cigarette products and smokeless tobacco products, will find this session meaningful.
Who should attend?
Finally, anyone who is acting as a consultant or contractor to a company in an FDA-regulated industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment.
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Charles H. Paul,
- Robert J. Russell,
- Greg Sperla and Anthony J. Cortez,
- Jeff Kasoff, RAC, CMQ/OE, LBB
- Danielle DeLucy, MS
- Norma Skolnik,
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.