FDA 21 CFR 820 cGMP Requirements

This ON DEMAND 6-hour e-course teaches the Quality System Regulations (QSR) and Current Good Manufacturing Practices (cGMP) required by the FDA for Medical Devices and includes a certified training Certificate of Competence. 0.6 CEUs.

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Course curriculum

  1. 1
    • How to use this course

  2. 2
    • FDA 21 CFR 820 CGMP Requirements _Lesson-01

    • FDA 21 CFR 820 CGMP Requirements _Lesson-01-QUIZ

  3. 3
    • FDA 21 CFR 820 CGMP Requirements _Lesson-02

    • FDA 21 CFR 820 CGMP Requirements _Lesson-02-QUIZ

  4. 4
    • FDA 21 CFR 820 CGMP Requirements _Lesson-03

    • FDA 21 CFR 820 CGMP Requirements _Lesson-03-QUIZ

  5. 5
    • FDA 21 CFR 820 CGMP Requirements _Lesson-04

    • FDA 21 CFR 820 CGMP Requirements _Lesson-04-QUIZ

  6. 6
    • FDA 21 CFR 820 CGMP Requirements _Lesson-05

    • FDA 21 CFR 820 CGMP Requirements _Lesson-05-QUIZ

  7. 7
    • FDA 21 CFR 820 CGMP Requirements _Lesson-06

    • FDA 21 CFR 820 CGMP Requirements _Lesson-06-QUIZ

  8. 8
    • FDA 21 CFR 820 CGMP Requirements _Lesson-07

    • FDA 21 CFR 820 CGMP Requirements _Lesson-07-QUIZ

  9. 9
    • FDA 21 CFR 820 CGMP Requirements _Lesson-08

    • FDA 21 CFR 820 CGMP Requirements _Lesson-08-QUIZ

  10. 10
    • Congratulations

Learning Objectives

Upon completion of this training, students will be able to:

  • Understand the requirements of the FDA 21 CFR Part 820 Quality System Regulations

  • Understand quality system definitions, concepts, and guidelines

  • Understand the roles and responsibilities to support CGMP compliance

  • Apply CGMP principles and best practices

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