Certificate in Global AM Regulatory Framework Essentials

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The Certificate in Global AM Regulatory Framework Essentials is a comprehensive course that provides learners with a solid understanding of the regulatory landscape in the Aerospace and Defense industry. This course is crucial in a world where strict compliance guidelines are essential for any organization dealing with aerospace and defense products or services.

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With increasing demand for regulatory expertise, this course equips learners with essential skills to navigate complex regulations and stay ahead in their careers. Learners will gain an in-depth knowledge of regulations such as ITAR, EAR, and Export Controls, among others. They will also learn how to implement effective compliance programs, ensuring their organizations remain compliant with ever-evolving regulations. By the end of this course, learners will have a solid foundation in the global AM regulatory framework and be able to apply their knowledge in real-world scenarios. This course is ideal for professionals looking to advance their careers in the Aerospace and Defense industry, including engineers, managers, compliance officers, and legal professionals.

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โ€ข Introduction to AM Regulatory Framework: Understanding the global regulatory landscape for Additive Manufacturing (AM), including key organizations and guidelines.
โ€ข Regulatory Requirements for AM Materials: Exploring the specific regulations and standards for AM materials, including metals, polymers, and composites.
โ€ข Design and Production Controls for AM: Examining design and production controls for AM, including design validation, process validation, and quality management.
โ€ข Part 21 of the European Union Aviation Safety Agency (EASA): Understanding Part 21 of the EASA, which outlines the requirements for the design and production of aircraft and related products.
โ€ข Medical Devices Regulations and AM: Exploring the regulations and guidelines for AM in the medical device industry, including the Food and Drug Administration (FDA) and Medical Device Single Audit Program (MDSAP).
โ€ข AM in the Aerospace Industry: An in-depth look at the regulations and best practices for AM in the aerospace industry, including the Federal Aviation Administration (FAA) and European Aviation Safety Agency (EASA).
โ€ข AM in the Automotive Industry: Examining the regulations and best practices for AM in the automotive industry, including the National Highway Traffic Safety Administration (NHTSA) and International Organization for Standardization (ISO).
โ€ข Risk Management in AM: Understanding the risk management process for AM, including hazard identification, risk assessment, and risk mitigation.
โ€ข Post-Market Surveillance for AM Products: Exploring the post-market surveillance requirements for AM products, including reporting, tracking, and corrective action.

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In the **Certificate in Global AM Regulatory Framework Essentials**, students will gain a comprehensive understanding of the regulatory landscape for medical devices and pharmaceuticals. The program covers essential aspects of regulatory affairs, quality assurance, and compliance, providing students with a solid foundation in this field. Here are some key roles in the industry and their respective job market trends, as represented by the 3D pie chart above: 1. **QA Engineer**: Quality Assurance Engineers are responsible for ensuring that medical devices and pharmaceuticals comply with regulatory and industry standards. With a 25% share, this role demonstrates a strong demand in the job market. 2. **Regulatory Affairs Specialist**: These professionals handle the regulatory strategies and submissions for medical device and pharmaceutical companies. This role represents 30% of the market, indicating a high demand for expertise in regulatory affairs. 3. **Compliance Officer**: Compliance Officers ensure that their organizations adhere to all applicable regulations and standards. This role accounts for 15% of the job market. 4. **Clinical Research Associate**: CRAs manage clinical trials to ensure their scientific validity and regulatory compliance. This role represents 20% of the job market. 5. **Data Manager**: Data Managers are responsible for collecting, maintaining, and analyzing clinical trial data. This role accounts for 10% of the job market. These roles require a strong understanding of global AM regulatory frameworks, providing excellent career opportunities for professionals with relevant skills and certifications.

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CERTIFICATE IN GLOBAL AM REGULATORY FRAMEWORK ESSENTIALS
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London College of Foreign Trade (LCFT)
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05 May 2025
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