Tracking and Controlling Employee Training Records and Requirements in FDA-regulated Environments

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 requirement and examines the associated challenges for meeting the requirement and the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking requirements is presented.

Topics include:

--FDA's regulatory requirements for employee training and training tracking
--Challenges of controlling training and records
--Paper approach to managing and tracking training
--Hybrid approach (paper and electronic) to managing and tracking training
--Electronic approach to managing and tracking training

Watch Customer Video MasterControl Training Module (2:29) Using MasterControl for FDA Compliance (3:53)

Downloads:

	White Paper: Automating Training Control Processes to Comply with FDA and ISO Requirements
	White Paper: Change Control - Quality Improvements in FDA and ISO Environments
	White Paper: Automating Document Control Processes to Comply with FDA and ISO Requirements

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