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This CPE 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 the 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.
With the help of this CPE Information technology course, 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.
We will address all three phases of CSV testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Each phase has specific requirements and the approach taken is critical in terms of the resources and time required.
In this Online CPE Webinar course speaker, Carolyn Troiano will discuss ways to minimize costs while assuring maximum compliance with FDA requirements for CSV.
Account Executive, BrainStorm Central Consulting LLC
Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, 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.
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MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478
MY-CPE LLC (Sponsor Id#: 143597) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.NASBARegistry.org.
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