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.
V360 Training Advantages
Certified Training Recognized Globally
Digitally verifiable certificates issued by a trusted global training provider.

Course curriculum
-
1
-
How to use this course
-
-
2
-
FDA-GMP-Pharmaceutical_Lesson-02
-
FDA-GMP-Pharmaceutical_Lesson-02_QUIZ
-
-
3
-
FDA-GMP-Pharmaceutical_Lesson-03
-
FDA-GMP-Pharmaceutical_Lesson-03_QUIZ
-
-
4
-
FDA-GMP-Pharmaceutical_Lesson-04
-
FDA-GMP-Pharmaceutical_Lesson-04_QUIZ
-
-
5
-
FDA-GMP-Pharmaceutical_Lesson-05
-
FDA-GMP-Pharmaceutical_Lesson-05_QUIZ
-
-
6
-
FDA-GMP-Pharmaceutical_Lesson-06
-
FDA-GMP-Pharmaceutical_Lesson-06_QUIZ
-
-
7
-
FDA-GMP-Pharmaceutical_Lesson-07
-
FDA-GMP-Pharmaceutical_Lesson-07_QUIZ
-
-
8
-
FDA-GMP-Pharmaceutical_Lesson-08
-
FDA-GMP-Pharmaceutical_Lesson-08_QUIZ
-
-
9
-
FDA-GMP-Pharmaceutical_Lesson-09
-
FDA-GMP-Pharmaceutical_Lesson-09_QUIZ
-
-
10
-
FDA-GMP-Pharmaceutical_Lesson-10
-
FDA-GMP-Pharmaceutical_Lesson-10_QUIZ
-
-
11
-
ISO 13485-Lesson-02
-
ISO 13485-Lesson-01 and 02-QUIZ
-
-
12
-
ISO 13485-Lesson-03
-
ISO 13485-Lesson-03-QUIZ
-
-
13
-
ISO 13485-Lesson-04a
-
ISO 13485-Lesson-04a-QUIZ
-
ISO 13485-Lesson-04b
-
ISO 13485-Lesson-04b_QUIZ
-
-
14
-
ISO 13485-Lesson-05
-
ISO 13485-Lesson-05-QUIZ
-
-
15
-
ISO 13485-Lesson-06
-
ISO 13485-Lesson-06-QUIZ
-
-
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
-
ISO 13485-Lesson-08a
-
ISO 13485-Lesson-08a-QUIZ
-
ISO 13485-Lesson-08b
-
ISO 13485-Lesson-08b-QUIZ
-
-
18
-
ISO 19011-2018 Auditing_Lesson-01-02
-
-
19
-
ISO 19011-2018 Auditing_Lesson-03
-
ISO 19011-Lesson-03-QUIZ
-
-
20
-
ISO 19011-2018 Auditing_Lesson-04
-
ISO 19011-Lesson-04-QUIZ
-
-
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
-
ISO 19011-2018 Auditing_Lesson-Annex
-
ISO 19011-Lesson-Annex-QUIZ
-
-
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
-
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
Other Recommended Courses
-
$895.00
Certified Quality Manager (CQM) Medical Devices
The Certified Quality Manager Medical Devices is a 44-hour training program for three ON DEMAND e-courses. ISO 13485:2016 Lead Auditor, ISO 14971:2019 Medical Device Risk Management Requirements, and FDA 21 CFR 820 cGMP Requirements. 4.4 CEUs.
-
$795.00
GMP-Pharma - Training Bundle
The GMP Pharma training bundle includes three ON DEMAND e-courses, including GMP Pharma Lead Auditor ISO 14971 Risk Management Medical Devices Requirements, and Failure Mode and Effects Analysis (FMEA).
-
$495.00
Validation - Training Bundle
The ISO Validation training program includes four ON DEMAND e-courses including Process Validation, Software Validation, Sampling for Validation, and Measurement System Analysis. 1.2 CEUs.
Globally recognized and trusted online training provider for leading medical device customers








