FDA Regulations

  1. This course identifies how user facilities, importers, and manufacturers report adverse events. It explores the proper forms to use to report adverse events, as well as the timeframes for reporting. It also discusses when it is not necessary to report an event.
    $99.95
    45 min
    Lesson
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  2. This course discusses important terms crucial to understanding the MDR regulation. It also discusses the MDR requirements as they relate to user facilities, importers, and manufacturers. It explores the requirements for MDR procedures and event files.
    $99.95
    45 min
    Lesson
    Add to Cart
  3. This course discuses the origin and evolution of the Medical Device Reporting (MDR) regulation. It describes the key characteristics of the MDR regulation and its preamble, as well as the key terms used in the MDR regulation. It also explores to whom the MDR regulation applies and who can be exempt.
    $99.95
    45 min
    Lesson
    Add to Cart
  4. FDA32_CN FDA Establishment Inspection (EI) (Simplified Chinese) FDA performs approximately 15,000 establishment inspections (EIs) per year. On completion of this course the learner will be able to identify the statutory authority for establishment inspections, as well as be able to recognize the procedures to prepare for, conduct, and conclude inspections. 45 Minutes
    $0.00
    45 min
    Lesson
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  5. BIMO05 BIMO: Sponsor/Monitor Responsibilities This course focuses on the responsibilities of sponsors and monitors of clinical research involving unapproved test articles that are under the jurisdiction of the FDA. 60 Minutes
    $99.95
    60 min
    Lesson
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  6. BIMO04 BIMO: Clinical Investigator Responsibilities This course focuses on the responsibilities of a clinical investigator who participates in clinical research involving unapproved test articles that are under FDA’s jurisdiction. 60 Minutes
    $99.95
    60 min
    Lesson
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  7. DCRI_14 China Food and Drug Administration (CFDA): Clinical Trial Regulation in China This course provides an overview of clinical trial regulation in China, as overseen by the China Food and Drug Administration of the People’s Republic of China (CFDA). 30 Minutes
    $99.95
    30 min
    Lesson
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  8. PHDV74_JP Handling an FDA Inspection (Japanese) The first step to a successful FDA inspection is to clarify roles and responsibilities of personnel during the inspection. It is critical for success that all involved members of the organization be prepared. This interactive program reviews the basics of handling an FDA GMP inspection and features an interactive fictional inspection... Learn More...
    $99.95
    45 min
    Lesson
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  9. In this course, you will learn key concepts and definitions necessary to understand Risk Management. The course focuses on Risk Management as it applies to FDA and its regulated industries. This course is also designed to provide an understanding of Risk Management as defined by the International Organization for Standardization (ISO).
    $99.95
    60 min
    Lesson
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  10. This course will provide the learner with an understanding of the change in enforcement policy of FDA for 21 CFR Part 11, Electronic Records; Electronic Signatures. The course discusses the Guidance for Industry; Part 11, Electronic Records; Electronic Signatures – Scope and Application, August 2003.
    $99.95
    20 min
    Lesson
    Add to Cart

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