Computerized system validation training

If your job (position) is one that holds you responsible for how your company’s or plant’s computerized control systems perform, you should keep reading.


If your job (position) is one that holds you responsible for how your company’s or plant’s computerized control systems perform, you should keep reading.

My June 2003 article, ''How to accelerate commissioning'' encourages those responsible for the ''care and feeding'' of computerized control systems to consider adopting existing good control system engineering practices. In the article I mentioned the International Society of Pharmaceutical Engineers’ (ISPE) ''Good Automation Manufacturing Practice'' (GAMP) as a helpful, available resource.

For those seeking ways to put the ideas I presented in the article to work, ISPE and EduNeering are offering a series of online computer system validation training courses to anyone wanting to take them.

Two things make this a unique opportunity. First, course content development and administration is the result of a joint effort between the U.S. Food and Drug Administration (FDA,, EduNeering, and ISPE. Second, these are the same courses being administered to the nearly 5,000 FDA state and local enforcement staff and authorized agents. It’s like having end-users and enforcement personnel sitting in the same classroom, listening to the same instructor, and working on the same assignment’s at the same time. The most recent course, ''Requirements for computerized system validation and compliance,'' will be of special interest to those who manage the validation of computer systems in regulated life sciences industries.

Through a cooperative research and development agreement, EduNeering is the first to partner with the FDA for compliance learning technology solutions. To learn more about EdNeering’s courses including the basics of investigation, food and drug law, Good Manufacturing Practices, quality systems regulations, validation, and Part 11 compliance, click here .

Click here to learn more about GAMP and/or courses on control system validation.

—Dave Harrold, Senior Editor,

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