Global Certificate in FDA Human Factors Studies

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The Global Certificate in FDA Human Factors Studies is a comprehensive course that equips learners with critical skills in Human Factors studies, a crucial aspect of product development in many industries. This course is essential for professionals working in regulated environments, particularly those involved in medical device, pharmaceutical, or combination product development.

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Über diesen Kurs

With the increasing focus on patient safety and product usability, the demand for experts in Human Factors is on the rise. This course, aligned with FDA guidelines, provides learners with a solid understanding of Human Factors principles, user research methods, and the application of these concepts in real-world scenarios. By the end of this course, learners will have developed a deep understanding of Human Factors studies, enhancing their career prospects and their ability to contribute to the safety and efficacy of products. They will be able to conduct user research, apply Human Factors principles in design, and evaluate product usability - all essential skills for career advancement in this field.

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Kursdetails

• Introduction to FDA Human Factors Studies: Understanding the regulatory context, key definitions, and the role of human factors in product design and development.
• User Research and Data Collection: Techniques for collecting and analyzing user data, including observations, interviews, and usability testing.
• User-Centered Design Principles: Applying user-centered design principles to the development of medical devices, including considerations for user interface design, labeling, and instructions for use.
• Risk Management in Human Factors Studies: Identifying and assessing risks associated with medical device use, and applying risk management principles to mitigate those risks.
• Usability Testing Methods: Designing and conducting usability tests, including test planning, execution, and data analysis.
• Human Factors in Software as a Medical Device: Understanding the unique challenges and considerations for human factors in software as a medical device.
• Human Factors in Medical Device Integration: Addressing human factors challenges in medical device integration, including interoperability and cybersecurity considerations.
• Human Factors in Post-Market Surveillance: Applying human factors principles to post-market surveillance, including incident reporting and investigation, and corrective action.
• Regulatory Compliance and Submission: Understanding the regulatory requirements for human factors studies, and preparing and submitting human factors data to the FDA.

Note: The above list serves as a general guideline and may be subject to change based on the specific requirements and scope of the course.

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Zugangsvoraussetzungen

  • Grundlegendes Verständnis des Themas
  • Englischkenntnisse
  • Computer- und Internetzugang
  • Grundlegende Computerkenntnisse
  • Engagement, den Kurs abzuschließen

Keine vorherigen formalen Qualifikationen erforderlich. Kurs für Zugänglichkeit konzipiert.

Kursstatus

Dieser Kurs vermittelt praktisches Wissen und Fähigkeiten für die berufliche Entwicklung. Er ist:

  • Nicht von einer anerkannten Stelle akkreditiert
  • Nicht von einer autorisierten Institution reguliert
  • Ergänzend zu formalen Qualifikationen

Sie erhalten ein Abschlusszertifikat nach erfolgreichem Abschluss des Kurses.

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Schnellkurs: GBP £149
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GLOBAL CERTIFICATE IN FDA HUMAN FACTORS STUDIES
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05 May 2025
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