• In-Depth Testing of Computer Systems Regulated by FDA - What You Need to Know?
  • In-Depth Testing of Computer Systems Regulated by FDA - What You Need to Know?

    • Speaker : Carolyn Troiano
    • Session Code : CTMAY2821
    • Date : 28th May 2021
    • Time : This Event is Over and the Recorded Copy is Available
    • Duration : 1 Hour 24 Mins


This webinar will focus on testing as a key element of Computer System Validation (CSV). Attendees 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 in the Webinar:


This course includes the following key areas of learning:


  • 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.


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.


Testing is one of the most crucial aspects of computer system validation, and must be planned, executed and documented carefully.


Preparedness will also help improve your relationship with the agency and ensure a more cooperative and successful audit experience. You will be in a very solid position to defend your validation efforts and the underlying systems and data. The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process.


What industries will benefit from your training:


Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:


  • Pharmaceutical (for drug products introduced using a medical device)
  • Medical Device
  • Biologicals (for biological products introduced using a medical device)
  • Tobacco (based on the Tobacco Control Act of 2009)
  • E-Liquid/Vapor (based on the “Deeming” Act of 2016)
  • E-Cigarette (based on the “Deeming” Act of 2016)
  • Cigar (based on the “Deeming” Act of 2016)
  • Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
  • Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA


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
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • 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

Carolyn Troiano has more than 35 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.

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Tags: Computer Systems Regulations, FDA requirements, testing, carolyn troiano, May 2021, webinar, amorit education