2014 - Legal, Regulatory and Policy Issues Related to Computer System Validation as the FDA Regulates Tobacco Products

Instructor: Carolyn Troiano
Description:
We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process), specifically as it relates to the tobacco industry. Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
In recent years, the FDA has brought tobacco products under their regulatory jurisdiction, and have applied guidelines for validation of computer systems used in the manufacture, testing or tracking of tobacco-related products. This includes cigarettes, cigars, e-cigarettes and other forms of smokeless tobacco, such as "pouch" products. 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.
This course will describe the best practices for developing a strategy and conducting validation work, including roles and responsibilities, and the procedures that should be followed. 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 addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11), as these have come under FDA regulations in the late 1990's. Specific criteria must be met in order to consider such a record or signature as valid in the eyes of FDA regulators.
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device and other regulated industries. Most recently, FDA has taken responsibility for oversight of companies in the tobacco-related industries, which are now subject to the same compliance requirements. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.
Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment, including those managed by tobacco-related industries.
Why Should you Attend:
You should attend this seminar if you are responsible for planning, executing or managing the validation of a system governed by FDA regulations, specifically in relation to tobacco products. This includes cigarettes, as well as the more recently developed e-cigarette products and smokeless tobacco products.
Effective and compliant computer system validation is critical to any FDA-regulated organization, including those manufacturing, testing and distributing tobacco products. During the past 30 years, best practices that have been developed will 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.
There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available to assure a compliant validation process.
Objectives of the Presentation:
Upon completion of this session, attendees will have an understanding of computer system validation planning, execution and management concepts, and how these efforts are to be adequately documented to meet FDA requirements for tobacco-related products. They will understand the steps required for a compliant validation process, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program for their organization.
Who can Benefit:
Information technology analysts, QC/QA managers and analysts, clinical data managers and scientists, analytical chemists, compliance managers, lab managers, automation analysts, computer system validation specialists, GMP training specialists, business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit. This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
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