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Courses
GMP Trainings
cGMP for Finished Pharmaceuticals (USFDA Focused)
Curriculum
10 Sections
10 Lessons
20 Hours
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Claim of Compliance
1
1.1
Introduction
Module 1
2
2.1
Foundations of GMP – History, Purpose, and Regulatory Framework
75 Minutes
2.2
Questionnaire
5 Questions
Module 2
2
3.1
The Pillar of Quality – Organization, Personnel, and The Quality Control Unit
75 Minutes
3.2
Questionnaire
5 Questions
Module 3
2
4.1
The Foundation of Quality – Buildings and Facilities
75 Minutes
4.2
Questionnaire
5 Questions
Module 4
2
5.1
The Tools of Production – Equipment
75 Minutes
5.2
Questionnaire
5 Questions
Module 5
2
6.1
The Building Blocks – Control of Components and Drug Product Containers and Closures
75 Minutes
6.2
Questionnaire
5 Questions
Module 6
2
7.1
The Heart of Manufacturing – Production and Process Controls
75 Minutes
7.2
Questionnaire
5 Questions
Module 7
2
8.1
The Final Check – Packaging, Labeling, and Holding/Distribution
75 Minutes
8.2
Questionnaire
5 Questions
Module 8
2
9.1
The Evidence of Quality – Laboratory Controls, Stability, and Records
90 Minutes
9.2
Questionnaire
5 Questions
Module 9
2
10.1
Handling The Unexpected – Returned and Salvaged Drug Products
60 Minutes
10.2
Questionnaire
5 Questions
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