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Introduction to Computer System Validation

Susan Marshall, P.E., MBA

This course provides an introduction to Computer System Validation (CSV) as defined in GAMP 5, which is the leading industry guidance on computer system compliance. GAMP is an acronym for “Good Automated Manufacturing Practice” and is published by ISPE (International Society of Pharmaceutical Engineers). While GAMP 5 is not a regulation, FDA and other regulatory bodies expect GAMP 5 principles to be applied to control and manage computerized and software system. GAMP 5 is accepted and embraced internationally beyond the pharmaceutical manufacturing industry and is used widely in all regulated and many less regulated industries.

This course includes a multiple-choice quiz at the end, which is designed to enhance the understanding of the course materials.

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NY PE & PLS: You must choose courses that are technical in nature or related to matters of laws and ethics contributing to the health and welfare of the public. NY Board does not accept courses related to office management, risk management, leadership, marketing, accounting, financial planning, real estate, and basic CAD. Specific course topics that are on the borderline and are not acceptable by the NY Board have been noted under the course description on our website.

AIA Members: You must take the courses listed under the category "AIA/CES Registered Courses" if you want us to report your Learning Units (LUs) to AIA/CES. If you take courses not registered with AIA/CES, you need to report the earned Learning Units (not qualified for HSW credits) using Self Report Form provided by AIA/CES.