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Automating Training Control Processes

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White Paper 1 Automating Training Control Processes to Comply with FDA and ISO Requirements Introduction FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training (21 CFR 211.25 and 820.25). These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This paper identifies the basis for the training requirement and examines the associated challenges for meeting the requirement and the shortcomings that lead to general system failures. It also presents a new approach for meeting and going beyond the tracking requirements. Why Track Training? Implementing and tracking employee training is a sound business practice that allows companies to know: • Employees are properly trained to correctly perform their tasks. • Which tasks specific employees can perform. • Employees can competently perform specific tasks. Without this fundamental information, organizations: • Create poor quality products. • Create products at a much higher cost due to inefficiencies, scrap, rework, etc. • Eventually fail on account of financial losses due to systemic failures or legal repercussions. The auditor's mantra is: "If it isn't documented, it didn't happen." While entire chapters and books have been written about ISO Certification requirements, suffice it to say, to attain ISO certification, auditors require documented proof of a planned and systematic training process. Moreover, tracking and documenting training is a legal requirement with regulated companies, including those regulated by the FDA, for the purpose of ensuring product quality. Simply, the stakes are too risky when dealing with ingested or injected products; therefore, the FDA legally mandates documented proof of required and completed training. Tracking Training – How Hard Can It Be? After accepting the fact that tracking employee training is required, most people presume that it is a relatively easy process. A common question is: "How hard can it be?" The key information required to track training is: • Understanding what training is required. • Knowing what training has been completed.

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