Device company employees need training, too


While pharma is, generally speaking, well aware of the need to train company employees in industry and company rules and regs, device companies aren't exempt. According to a press release sent to promote a link to this white paper, "Tracking & Controlling Employee Training Records & Requirements in FDA Environments":

    The FDA stipulates personnel training requirements for medical device companies in 21 CFR Part 820.25 and for pharmaceutical companies in 21 CFR Part 211.25. For businesses that adhere to ISO standards, ISO 9001:2000 Clause 6.2.2 specifies that records must be maintained detailing the training, experience, and skills of all employees with assignments related to the ISO 9001:2000 requirements.

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