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. How to use this course

    1. FDA 21 CFR 820 CGMP Requirements _Lesson-01

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

    1. FDA 21 CFR 820 CGMP Requirements _Lesson-02

    2. FDA 21 CFR 820 CGMP Requirements _Lesson-02-QUIZ

    1. FDA 21 CFR 820 CGMP Requirements _Lesson-03

    2. FDA 21 CFR 820 CGMP Requirements _Lesson-03-QUIZ

    1. FDA 21 CFR 820 CGMP Requirements _Lesson-04

    2. FDA 21 CFR 820 CGMP Requirements _Lesson-04-QUIZ

    1. FDA 21 CFR 820 CGMP Requirements _Lesson-05

    2. FDA 21 CFR 820 CGMP Requirements _Lesson-05-QUIZ

About this course

  • $395.00
  • 18 lessons
  • 1 hour of video content

Learning Objectives

After completing this training, students will:

  • Understand quality management definitions, concepts, and guidelines for FDA 21 CFR Part 820 Quality System Regulations

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

  • Understand the roles and responsibilities to support CGMP compliance

  • Know the records required for internal and external audits

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