Importance of training control in FDA and ISO environments

White Paper explains significance of training control in FDA and ISO environments

July 11, 2006 — /MasterControl/ — SALT LAKE CITY, Utah — Training control is historically one of the top 10 problem areas that cause Form FDA-483 citations.

Life sciences personnel are required to undergo continuous training in GxP regulations, and FDA investigators typically review employee competency whenever a deviation is observed during inspection. Companies certified to ISO 9001:2000 have similar training requirements to ensure that employees know how to perform their duties within company and industry guidelines.

White Paper Description:
This white paper prepared by MasterControl talks about the most common stumbling blocks in training management. It discusses the following:

–Why track training? (FDA regulations and ISO standards that require training control.)
–Tracking training: how hard can it be? (Major challenges in implementing training.)
–Comparison of different systems – paper-based, hybrid, and automated – and the different options available under each approach.
–The MasterControl solution.

About MasterControl
MasterControl Inc. has been at the forefront of providing innovative quality management software solutions since 1993. Over 400 companies worldwide use the MasterControl solution to consistently meet FDA regulations, ISO standards, and other regulatory requirements. In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. For more information or additional white papers, visit or call 800-825-9117.


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