GMP Pharma Internal Auditor [English]

GMP Pharma Internal Auditor

This 32-hour e-course teaches an understanding of the 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.

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Course Curriculum

1. How to use this course
1. SHO-Student Handout_ISO Audit Reference-ENGLISH_V01
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. Case Studies for Auditing-Definitions
2. Video-Case-Study-Definitions
3. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-01
4. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-02
5. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-03
6. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-04
7. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-05
8. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-06
9. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-07
10. FDA-GMP-Pharma-Case Studies for Auditing_QUIZ-08
1. Video-Congratulations-Next Steps

GMP Pharma Internal Auditor

$1,095.00
On Demand / Student-Paced
32 hours / 3.2 CEUs
English
Certified Training

Learning Objectives

Understand FDA 21 CFR 210 and 211 Pharmaceutical CGMP and ISO 13485 definitions, concepts, and guidelines
Know the requirements of the FDA 21 CFR 210 and 211 Pharmaceutical CGMP regulations and ISO 13485 quality management standard
Understand the process approach
Know the records required for internal and external audits
Realize the roles and responsibilities of the auditor
Be capable of conducting all phases of an audit using a risk-based approach and identifying nonconformances
Understand the requirements for planning the audit and conducting the opening and closing meetings
Know methods to prepare audit conclusions and the audit report

Certified Training Recognized Globally

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Our certificates are secure, digitally issued, and verifiable online by any third-party, registrar, or certification body. You can easily add your credential to your LinkedIn or other social media profile.

Enroll Now $1095

GMP Pharma Internal Auditor

Course Curriculum

Welcome to the course!

Student Handouts

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

GMP Pharma Internal Auditor

Learning Objectives

Certified Training Recognized Globally