Effective Training Yields Learning and Growth

摘要

From the FDA's perspective, training requirements seem straightforward (ref. 21CFR820.25 (b)): Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. This certainly makes sense; anyone (including contract and temporary employees) affecting the quality management system (QMS) needs to be qualified objectively. Additionally, (1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs and (2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions. These two requirements directly relate to the fact that everyone's actions can potentially impact the safety and effectiveness of finished medical devices.