GMP Pharma Lead Auditor

This ON DEMAND 40-hour e-course teaches a detailed understanding of the concepts and requirements of FDA 21 CFR 210 and 211 Pharmaceutical CGMP, ISO 13485, and ISO 19011 Lead Auditing. Includes a certified training Certificate of Competence. 4.0 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-05a

    • ISO 19011-Lesson-05a-QUIZ

    • ISO 19011-2018 Auditing_Lesson-05b

    • ISO 19011-Lesson-05b-QUIZ

    • ISO 19011-2018 Auditing_Lesson-05c

    • ISO 19011-Lesson-05c-QUIZ

    • ISO 19011-2018 Auditing_Lesson-05d

    • ISO 19011-Lesson-05d-QUIZ

  22. 22
    • 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

  23. 23
    • ISO 19011-2018 Auditing_Lesson-07a

    • ISO 19011-Lesson-07a-QUIZ

    • ISO 19011-2018 Auditing_Lesson-07b

    • ISO 19011-Lesson-07b-QUIZ

  24. 24
    • ISO 19011-2018 Auditing_Lesson-Annex

    • ISO 19011-Lesson-Annex-QUIZ

  25. 25
    • 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

  26. 26
    • 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 regulations and ISO 13485 quality management 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

Course Categories

Lead Auditor | Internal Auditor | Requirements | Overview

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