Regulatory Compliance and Employee Training Management
In today's FDA-regulated environment, life science companies must implement employee training. Employee training management helps ensure that company personnel know how to perform their duties according to approved company standard operating procedures. When employees know how to perform the results are higher quality products. MasterControl is the leading provider of content and quality management systems. The MasterControl employee training management software solutions address the major challenges companies face in conducting enterprise-wide training
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Employers understand that employee training is essential for their organization’s success. This is especially important for pharmaceutical companies, where employee training can reduce the risk of nonconformance. In FDA’s “Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations,” it states, “Under a quality system, continued training is critical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations. Typical quality systems training should address the policies, processes, procedures, and written instructions related to operational activities, the product/service, the quality system, and the desired work culture (e.g., team building, communication, change, behavior). Under a quality system (and the CGMP regulations), training should focus on both the employees’ specific job functions and the related CGMP regulatory requirements.”
FDA’s Quality System Regulation 21 CFR 820 also covers employee training management, stating that management “must establish procedures for identifying training needs and to ensure personnel are adequately trained.” This includes making employees aware of defects and errors that could be encountered as improper performance of their specific jobs.
Adverse events involving medical devices or equipment can lead to serious problems, including incorrect or delayed diagnosis and treatment or patient injuries. When errors involving medical devices recur repeatedly, users are often blamed. In reality, the fault may lie in poor training received on the manufacturing line. Problems may also arise with the user’s expectation of how the device works. If instructions are written poorly or if the device is incorrectly demonstrated, adverse events can be expected.
It’s clear that in both the pharmaceutical and medical device industries, employees must receive proper training to avoid making errors that could have serious ramifications. Human factors, those variables that affect the performance of individuals using equipment, can be mitigated through training and retraining. To meet FDA’s regulations, this training must be documented. Paper documentation could be used but it is much more efficient to use an electronic system that integrates training with proper documentation.
MasterControl's employee training management system is part of an integrated, easy to use suite specifically designed for companies seeking compliance to FDA regulations and ISO quality standards. The employee training application is web-based to more easily automate, streamline, and manage the entire training process to be faster and more cost-effective. And now, MasterControl also offers this training management system as part of a hosted on-demand cloud-based quality management system solution.
Here are some of MasterControl's Training Management features and benefits:
To learn more about MasterControl’s quality and compliance software, contact a MasterControl representative.