In-Depth Testing of Computer Systems Regulated by FDA

Duration: 75 Minutes
The Webinar will focus on testing as a key element of Computer System Validation (CSV). The level of testing must reflect both the potential risk associated with failure of the system to function properly. It must also be based on the systems' classification in accordance with GAMP 5, and on a thorough risk assessment of what could happen if the system were to fail. A standard risk approach will be explained to incorporate into the testing to be done.
Testing of Computer Systems Regulated by FDA
Instructor: Carolyn Troiano
Product ID: 504865
Objectives of the Presentation
  • Determine the category of your system, based on GAMP 5 from ISPE
  • Determine the risks associated with the various ways your system may fail
  • Use the category and risk, develop a rationale for the level of testing that will be needed to assure your system is thoroughly vetted
  • Understand the FDA requirements for documentation of all testing activities
  • Understand how to write a test protocol for each phase of testing:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ) [also referred to as User Acceptance Testing, or UAT]
  • Understand how to develop test scripts and acceptance criteria
  • Learn how to identify test discrepancies and distinguish the type: test script errors, tester errors, system errors
  • Learn how to document all testing and the summary reports
  • Learn about maintaining the system in a validated state, and keeping testing as a ‘living' exercise that runs through the system life cycle
  • Q&A
Why Should you Attend
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.

You will learn the way to develop a detailed rationale for testing and how to ensure that it is fully executed and documented in accordance with FDA requirements. You will also be provided with guidance for maintaining the system in a validated state and assessing the level of any testing that might be required post-validation to ensure that compliance.

Areas Covered
  • Computer System Validation (CSV) and the 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 and GAMP 5 system categorization to analyze the best approach to testing
  • Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way, and include only those that you are going to use to minimize testing requirements
  • System Design Specification (SDS) that details how the functional requirements will be delivered
  • Test Planning, including Development of Scenarios, Cases and Scripts (Installation Qualification, Operational Qualification and Performance Qualification)
  • Requirements Traceability Matrix (RTM) that connects the requirements, design and test elements
  • System Acceptance and Release Notification
  • Ongoing validation maintenance and governance and the role of testing in maintaining a system in a validated state throughout its life cycle
  • System Retirement steps to close out the life cycle
Who will Benefit
This webinar will provide valuable assistance to all personnel in:
  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • IT Developers, Designers, Testers and Support Personnel
  • 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
  • Auditors engaged in the internal inspection of labeling records and practices
Topic Background
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. You'll learn all about how to prepare your system validation documentation for an FDA audit of your company's computer systems.

One of the most critical aspects of validation is the testing phase, which includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). A protocol must be prepared and followed for each one, along with a summary report. These activities will ensure the system is properly installed, and that not only does the core functionality work, but it works in the way the user will challenge it during day-to-day operations.
$200
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • 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
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • 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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