Monday, September 19, 2011

Online GMP Training - 21 CFR 820: Essential Elements

An example of the stent used in an EVAR procedureImage via WikipediaTake this online CBT (computer based training) if you need to review the 21 CFR 820 regulations from the perspective of being inside a medical device manufacturing facility. Learn the rules affecting medical device manufacturing, while getting a glimpse of medical device production techniques.
This class is appropriate for all employees of medical device manufacturing organizations. Upon the completion of the class, employees will be able to summarize the 15 subparts.

Online computer-based training (CBT) is the way to complete required training at minimal cost.

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1 comment:

  1. The regulations start out by saying, "Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices." . . . my eyes are glazing over. This online CBT turns the regs into something very understandable. Check it out!

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