the-6-most-common-problems-in-fda-software-validation-and-verification-computer-system-validation-step-by-step

The 6 Most Common Problems in FDA Software Validation and Verification, Computer System Validation: Step-by-Step

Live Webinar

  • 60 minutes

This seminar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

Join this session by expert speaker Carolyn Troiano, where she will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.

Session Highlights:

  • Discuss the best practices necessary to ensure all systems are validated appropriately

  • Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk

  • Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state

  • Learn how to gain information about trends invalidation, as the industry progresses and new best practices emerge

  • Understand some of the key "pitfalls" to avoid when applying the SDLC methodology

Why You Should Attend:

  • Learn how to reduce the time and labor involved in a computer system validation effort by adequately planning your project

  • Learn how to ensure your team members are adequately trained to implement and maintain an FDA-regulated computer system in order to manage a successful outcome

  • Learn how efficient and effective testing can ensure that all deficiencies are captured before a system is put into production, allowing for a smooth go-live without delay

Who Should Attend:

  • Information Technology Analysts

  • QC/QA Managers

  • QC/QA Analysts

  • Clinical Data Managers

  • Clinical Data Scientists

  • Analytical Chemists

  • Compliance Managers

  • Laboratory Managers

  • Automation Analysts

  • Computer System Validation Specialists

  • GMP Training Specialists

  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance, and audit

  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance


*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Carolyn  Troiano

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).

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