Global Certificate in AM Regulatory Compliance: Smarter Compliance
-- ViewingNowThe Global Certificate in AM Regulatory Compliance: Smarter Compliance course is a comprehensive program designed to empower professionals with the necessary skills to navigate the complex world of additive manufacturing (AM) regulatory compliance. This course is crucial in today's industry, where AM technology is rapidly advancing and regulatory requirements are constantly evolving.
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โข Global AM Regulatory Compliance Overview — Understanding the complexities of global Additive Manufacturing (AM) regulatory compliance, including key challenges and best practices for smarter compliance. โข Regulatory Bodies & Standards — Exploring the major regulatory bodies and standards that govern AM, such as the FDA, ISO, and ASTM, to ensure a strong foundation in compliance. โข AM Design Control & Quality Management — Delving into the design control and quality management processes that are crucial for AM regulatory compliance, focusing on risk management, validation, and documentation. โข Materials & Processes Compliance — Examining the compliance considerations for AM materials and processes, including material qualification, process validation, and traceability. โข Post-Processing & Inspection Compliance — Investigating the regulatory requirements for post-processing and inspection in AM, covering critical steps like cleaning, heat treatment, and non-destructive testing. โข Part Submission & Labeling Requirements — Understanding the essential part submission and labeling requirements for global AM regulatory compliance, with a focus on FDA submission guidelines and UDI labeling standards. โข Supply Chain Management & Distribution — Discussing supply chain management and distribution considerations for AM regulatory compliance, addressing topics like vendor qualification, quality agreements, and logistics. โข Change Management & Continuous Improvement — Exploring change management and continuous improvement strategies for AM regulatory compliance, emphasizing the importance of proactive monitoring, reporting, and adaptation. โข Compliance Training & Auditing — Highlighting the significance of compliance training and auditing in maintaining regulatory compliance, providing guidance on creating effective training programs and conducting internal/external audits.
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