How to develop an appropriate computer system validation strategy to meet FDA requirements

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, May 10, 2018
90 minutes
Product Description

Learn to Apply System Development Life Cycle Methodology

The U.S. Food and Drug Administration (FDA) has high standards when it comes to computer system compliance and validation. You must design a process to consistently conform to requirements, and then run studies showing that the process works. And passing the validation process is no small task: You need standard operating procedures, detailed specifications, test plans, and more. Sound complicated? You bet it is.

Untangle your compliance confusion with Carolyn Troiano, who has more than 35 years of experience in the computer validation field. In this detailed audio conference, she’ll help you understand computer system validation (CSV) and how to apply the system development life cycle (SDLC) methodology when validating computer systems subject to FDA regulations.

After attending this audio event, you will be able to develop an appropriate validation strategy—as well as prove that your system does what it claims it can. You will also be able to maintain your system as it passes through its entire life cycle, from conception to retirement. Troiano will also discuss phases within the SDLC and how they form the basis for any CSV project. Most importantly, you’ll be up-do-date on FDA system requirements and SDLC methods.

Session Highlights

Here is a taste of what you will uncover:

  • CSV and how to apply SDLC when validating computer systems subject to FDA regulations
  • Good variable practices for manufacturing, laboratory, and clinical settings
  • Validation planning that takes into account the system risk assessment process and GAMP 5 system categorization
  • Functional requirements specification that includes detailed needs described in a specific and unique way
  • System design specifications that link design to functional requirements
  • Configuration management specifications that document the detailed configuration of the system
  • Test planning, including the development of scenarios, cases, and scripts
  • Good documentation practices
  • Data archival and governance systems which ensure security, integrity, and compliance
  • System retirement steps which close out the life cycle
  • How to produce a validation summary report
  • Requirement traceability matrices which connect the requirement, design, and test elements
  • Configuration management specifications that document the detailed configuration of the system
  • Test planning, including the development of scenarios, cases, and scripts (Installation Qualification, Operational Qualification, and Performance Qualification)

Who Should Attend

  • Information technology analysts
  • QC/QA managers and analysts
  • Clinical data managers and scientists
  • Analytical chemists
  • Compliance managers
  • Laboratory managers
  • Automation analysts
  • GMP training specialists
  • Computer system validation specialists
  • Business stakeholders responsible for computer system validation
  • Consultants in the life sciences industry involved in computer system validation
  • Everyone in FDA-regulated industries, including life sciences, pharmaceutical, biotech, medical device, and tobacco and related products
  • Auditors engaged in the internal inspection of labeling records and practices

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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