Legal, Regulatory and Policy Issues Related to FDA Compliance for Computer System Validation (CSV)

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, Feb 22, 2017
90 minutes
Product Description

Critical and Cost-Effective Methods, Techniques, Tools and Best Practices to Assure a Compliant Validation Process

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.

Learning Objectives

  • Understand the FDA regulations for computer systems used in the manufacture, clinical and quality testing, distribution, and post-marketing surveillance of pharmaceutical, medical device, biological, tobacco and related products.  
  • Understand how the FDA regulations have evolved and what to expect.
  • Learn about FDA oversight, how the agency operates, and what that means for your organization.
  • Learn to develop a compliance strategy, based on industry best practices, minimizing operational costs while complying with the FDA.
  • Know about specific criteria for electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11), in order to consider such a record or signature as valid in the eyes of FDA regulators.

Who should attend?

  • Manufacturing Analysts and Supervisors
  • Marketing Analysts and Managers
  • Information Technology Professionals
  • QC/QA Analysts and Managers
  • Laboratory Analysts and Managers
  • Compliance and Audit Managers
  • Automation Analysts and Managers
  • GMP Training Specialists
  • Computer System Validation Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Warehouse Managers

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.

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About Our Speaker

Carolyn Troiano - FDA Regulation Expert

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.

Carolyn has spent a number of years evaluating supply chain security and compliance, including technologies...   More Info
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