GMP Pharma Internal Auditor

This ON DEMAND 6-hour e-course teaches a detailed understanding of the concepts and best practices of the ISO 14971:2019 Medical Device Risk Management standard 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-GMP-Pharmaceutical_Lesson-02

    • FDA-GMP-Pharmaceutical_Lesson-02_QUIZ
  3. 3

    • FDA-GMP-Pharmaceutical_Lesson-03

    • FDA-GMP-Pharmaceutical_Lesson-03_QUIZ
  4. 4

    • FDA-GMP-Pharmaceutical_Lesson-04

    • FDA-GMP-Pharmaceutical_Lesson-04_QUIZ
  5. 5

    • FDA-GMP-Pharmaceutical_Lesson-05

    • FDA-GMP-Pharmaceutical_Lesson-05_QUIZ
  6. 6

    • FDA-GMP-Pharmaceutical_Lesson-06

    • FDA-GMP-Pharmaceutical_Lesson-06_QUIZ
  7. 7

    • FDA-GMP-Pharmaceutical_Lesson-07

    • FDA-GMP-Pharmaceutical_Lesson-07_QUIZ
  8. 8

    • FDA-GMP-Pharmaceutical_Lesson-08

    • FDA-GMP-Pharmaceutical_Lesson-08_QUIZ
  9. 9

    • FDA-GMP-Pharmaceutical_Lesson-09

    • FDA-GMP-Pharmaceutical_Lesson-09_QUIZ
  10. 10

    • FDA-GMP-Pharmaceutical_Lesson-10

    • FDA-GMP-Pharmaceutical_Lesson-10_QUIZ
  11. 11

    • ISO 13485-Lesson-02

    • ISO 13485-Lesson-01 and 02-QUIZ
  12. 12

    • ISO 13485-Lesson-03

    • ISO 13485-Lesson-03-QUIZ
  13. 13

    • ISO 13485-Lesson-04a

    • ISO 13485-Lesson-04a-QUIZ

    • ISO 13485-Lesson-04b

    • ISO 13485-Lesson-04b_QUIZ
  14. 14

    • ISO 13485-Lesson-05

    • ISO 13485-Lesson-05-QUIZ
  15. 15

    • ISO 13485-Lesson-06

    • ISO 13485-Lesson-06-QUIZ
  16. 16

    • ISO 13485-Lesson-07a

    • ISO 13485-Lesson-07a-QUIZ

    • ISO 13485-Lesson-07b

    • ISO 13485-Lesson-07b-QUIZ

    • ISO 13485-Lesson-07c

    • ISO 13485-Lesson-07c-QUIZ

    • ISO 13485-Lesson-07d

    • ISO 13485-Lesson-07d-QUIZ

    • ISO 13485-Lesson-07e

    • ISO 13485-Lesson-07e-QUIZ
  17. 17

    • ISO 13485-Lesson-08a

    • ISO 13485-Lesson-08a-QUIZ

    • ISO 13485-Lesson-08b

    • ISO 13485-Lesson-08b-QUIZ
  18. 18

    • ISO 19011-2018 Auditing_Lesson-01-02
  19. 19

    • ISO 19011-2018 Auditing_Lesson-03

    • ISO 19011-Lesson-03-QUIZ
  20. 20

    • ISO 19011-2018 Auditing_Lesson-04

    • ISO 19011-Lesson-04-QUIZ
  21. 21

    • ISO 19011-2018 Auditing_Lesson-06a

    • ISO 19011-Lesson-06a-QUIZ

    • ISO 19011-2018 Auditing_Lesson-06b

    • ISO 19011-Lesson-06b-QUIZ

    • ISO 19011-2018 Auditing_Lesson-06c

    • ISO 19011-Lesson-06c-QUIZ
  22. 22

    • ISO 19011-2018 Auditing_Lesson-Annex

    • ISO 19011-Lesson-Annex-QUIZ
  23. 23

    • FDA-GMP-Pharma-Case Studies for Auditing_V1

    • FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-01

    • FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-02

    • FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-03

    • FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-04

    • FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-05

    • FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-06

    • FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-07

    • FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-08
  24. 24

    • Congratulations

Learning Objectives

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

  • Understand FDA 21 CFR 210 and 211 Pharmaceutical CGMP and ISO 13485 definitions, concepts, and guidelines

  • Understand the requirements of the FDA 21 CFR 210 and 211 Pharmaceutical CGMP and ISO 13485 quality standard

  • Understand the roles and responsibilities of the auditor

  • Apply ISO 19011:2018 Management System Auditing concepts, new terminology and guidelines

  • Recognize the principles, practices, and types of audits

  • Conduct all phases of an audit adopting a risk-based approach

  • Prepare and present effective reports

  • Understand the role of objectives, scope and criteria in the audit process

  • How to plan audits and conduct audit team selection

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Course Categories

Lead Auditor | Internal Auditor | Requirements | Overview

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