GMP Pharma Internal Auditor

This ON DEMAND 32-hour e-course teaches a detailed understanding of the concepts and requirements of FDA 21 CFR 210 / 211 Pharma CGMP, ISO 13485, and ISO 19011 Internal Auditing. Includes a certified training Certificate of Competence. 3.2 CEUs.

Buy $500.00

Course curriculum

1. How to use this course
1. FDA-GMP-Pharmaceutical_Lesson-02
2. FDA-GMP-Pharmaceutical_Lesson-02_QUIZ
1. FDA-GMP-Pharmaceutical_Lesson-03
2. FDA-GMP-Pharmaceutical_Lesson-03_QUIZ
1. FDA-GMP-Pharmaceutical_Lesson-04
2. FDA-GMP-Pharmaceutical_Lesson-04_QUIZ
1. FDA-GMP-Pharmaceutical_Lesson-05
2. FDA-GMP-Pharmaceutical_Lesson-05_QUIZ
1. FDA-GMP-Pharmaceutical_Lesson-06
2. FDA-GMP-Pharmaceutical_Lesson-06_QUIZ
1. FDA-GMP-Pharmaceutical_Lesson-07
2. FDA-GMP-Pharmaceutical_Lesson-07_QUIZ
1. FDA-GMP-Pharmaceutical_Lesson-08
2. FDA-GMP-Pharmaceutical_Lesson-08_QUIZ
1. FDA-GMP-Pharmaceutical_Lesson-09
2. FDA-GMP-Pharmaceutical_Lesson-09_QUIZ
1. FDA-GMP-Pharmaceutical_Lesson-10
2. FDA-GMP-Pharmaceutical_Lesson-10_QUIZ
1. ISO 13485-Lesson-02
2. ISO 13485-Lesson-01 and 02-QUIZ
1. ISO 13485-Lesson-03
2. ISO 13485-Lesson-03-QUIZ
1. ISO 13485-Lesson-04a
2. ISO 13485-Lesson-04a-QUIZ
3. ISO 13485-Lesson-04b
4. ISO 13485-Lesson-04b_QUIZ
1. ISO 13485-Lesson-05
2. ISO 13485-Lesson-05-QUIZ
1. ISO 13485-Lesson-06
2. ISO 13485-Lesson-06-QUIZ
1. ISO 13485-Lesson-07a
2. ISO 13485-Lesson-07a-QUIZ
3. ISO 13485-Lesson-07b
4. ISO 13485-Lesson-07b-QUIZ
5. ISO 13485-Lesson-07c
6. ISO 13485-Lesson-07c-QUIZ
7. ISO 13485-Lesson-07d
8. ISO 13485-Lesson-07d-QUIZ
9. ISO 13485-Lesson-07e
10. ISO 13485-Lesson-07e-QUIZ
1. ISO 13485-Lesson-08a
2. ISO 13485-Lesson-08a-QUIZ
3. ISO 13485-Lesson-08b
4. ISO 13485-Lesson-08b-QUIZ
1. ISO 19011-2018 Auditing_Lesson-01-02
1. ISO 19011-2018 Auditing_Lesson-03
2. ISO 19011-Lesson-03-QUIZ
1. ISO 19011-2018 Auditing_Lesson-04
2. ISO 19011-Lesson-04-QUIZ
1. ISO 19011-2018 Auditing_Lesson-06a
2. ISO 19011-Lesson-06a-QUIZ
3. ISO 19011-2018 Auditing_Lesson-06b
4. ISO 19011-Lesson-06b-QUIZ
5. ISO 19011-2018 Auditing_Lesson-06c
6. ISO 19011-Lesson-06c-QUIZ
1. ISO 19011-2018 Auditing_Lesson-Annex
2. ISO 19011-Lesson-Annex-QUIZ
1. FDA-GMP-Pharma-Case Studies for Auditing_V1
2. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-01
3. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-02
4. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-03
5. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-04
6. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-05
7. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-06
8. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-07
9. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-08
1. Congratulations

About this course

$500.00
68 lessons
0 hours of video content

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Velocity 360 USA Training | UK

GMP Pharma Internal Auditor

Course curriculum

Welcome to the course!

Introduction - GMP Pharma

Terms and definitions

Subpart A – General Provisions | Subpart B – Organization and Personnel | Subpart C – Buildings and Facilities

Subpart D – Equipment

Subpart E – Control of Components and Drug Product Containers and Closures

Subpart F – Production and Process Controls

Subpart G – Packaging and Labeling Control

Subpart H – Holding and Distribution | Subpart I – Laboratory Controls

Subpart J – Records and Reports | Subpart K – Returned and Salvaged Drug Products

13485 - Overview | Clarification of Concepts | The Process Approach

13485 - Key Terms and definitions

13485 - Quality Management System

13485 - Management Responsibility

13485 - Resource Management

13485 - Product Realization

13485 - Measurement, Analysis and Improvement

ISO 19011 Auditing - Introduction | Scope

ISO 19011 Auditing - Terms and definitions

ISO 19011 Auditing - Principles of auditing

ISO 19011 Auditing - Conducting the audit

ISO 19011 Auditing - Annex A

FDA GMP Pharma - Case Studies for Auditing

Next Steps

About this course

Discover your potential, starting today