Most Common Challenges in FDA Software Validation and Verification, Computer System Validation and Overcoming them: Step-by-Step

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.

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 in the Session : 

• 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 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
• All FDA-regulated industries: Pharmaceutical, Biologicals, Medical Device, Tobacco, Animal Health

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.