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

Duration: 90 Minutes
This webinar 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. We 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.
Computer System Validation
Instructor: Carolyn Troiano
Product ID: 501303
Objectives of the Presentation
  • 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 in validation, as industry progresses and new best practices emerge
  • Understand some of the key "pitfalls" to avoid when applying the SDLC methodology
Why Should you Attend
Attend this webinar to learn more about computer system validation and the latest validation trends and how to ensure that all systems are validated in compliance with FDA regulations.

Areas Covered
  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy that will take into account the system risk assessment process
  • User Requirements Specification (URS) to include high-level needs in language familiar to the user
  • Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way
  • System Design Specification (SDS) that link design to functional requirements
  • Test Planning, including Development of Scenarios, Cases and Scripts
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ) (also referred to as User Acceptance Testing (UAT))
  • Requirements Traceability Matrix (RTM) that connects the requirements, design and test elements
  • System Acceptance by the user or owner of the system
  • System Release Notification once it is put into a production environment
  • System Retirement steps to close out the life cycle
  • Data Archival to ensure security, integrity and compliance
Who can Benefit
  • 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
  • All FDA-regulated industries: Pharmaceutical, Biologicals, Medical Device, Tobacco, Animal Health
$375
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  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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.
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