Global Certificate in Equipment Validation Audits
-- ViewingNowThe Global Certificate in Equipment Validation Audits is a comprehensive course designed to meet the growing industry demand for experts in equipment validation. This course emphasizes the importance of thorough validation audits, ensuring that medical devices, pharmaceutical equipment, and other critical systems comply with regulatory standards.
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⢠Equipment Validation Audits Foundation: Understanding the basics of equipment validation audits, their importance, and the regulatory requirements. ⢠Regulatory Framework: An in-depth analysis of the global regulations governing equipment validation audits, including FDA, EMA, and ICH guidelines. ⢠Equipment Validation Lifecycle: Exploring the different stages of the equipment validation lifecycle, from design and implementation to maintenance and retirement. ⢠Risk Management in Equipment Validation: Implementing risk management principles in equipment validation audits to ensure patient safety and regulatory compliance. ⢠Documentation and Record Keeping: Understanding the critical role of documentation and record keeping in equipment validation audits. ⢠Audit Preparation and Execution: Best practices for preparing for and executing equipment validation audits, including the development of audit checklists and plans. ⢠Audit Findings and Corrective Action: Identifying audit findings, determining the root cause, and implementing corrective action to prevent recurrence. ⢠Continuous Improvement in Equipment Validation: Implementing continuous improvement principles in equipment validation audits to ensure ongoing compliance and optimal performance.
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