基于GMP的产教融合：高职医疗器械类专业实训基地建设路径与机制研究
DOI:
https://doi.org/10.6938/ehjzk404Abstract
面对医疗器械监管日益严格与产业人才短缺的双重压力，本研究提出以GMP（良好生产规范）标准为核心的产教融合实训基地建设模式。通过深入分析GMP在硬件设施、软件体系及人员操作方面的刚性要求，揭示实训基地在建设过程中所面临的高投入成本、管理复杂性以及教学与合规性之间的矛盾等特殊挑战，创新性地构建了“标准嵌入、双元共治、过程管控、多元评价”的四位一体建设理念。在实践层面，设计了分层次的硬件集成体系，开发适用于教学场景的GMP文档体系，构建了盖全流程的合规实训项目，并提出了师资双向赋能的实施路径。同时，建立了动态法规响应机制、资源共享机制与风险防控机制。该建设模式为培养符合医疗器械行业法规要求的高素质技术技能人才提供了可复制、可推广的解决方案，对提升相关专业核心竞争力和服务产业升级具有重要的实践意义。
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