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GMP Training
ICH Q7 GMP Training
ICH Q7 GMP Training
Curriculum
20 Sections
39 Lessons
30 Hours
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Detailed Glossary
1
1.1
Key Terms
Introduction to ICH Q7
3
2.1
Module 1
2.2
Case Study – API Starting Material Determination
2.3
Questionnaire – Module 1
20 Minutes
5 Questions
Quality Management
Learning Outcomes
3
3.1
Module 2
3.2
Practical Exercise – Quality Unit Decision-Making
3.3
Questionnaire
5 Questions
Personnel Requirements
Learning Outcomes
3
4.1
MODULE 3
4.2
Practical Exercise – Training Program Development
4.3
Questionnaire
5 Questions
Buildings and Facilities
Learning Objectives
3
5.1
Module 4
5.2
Practical Exercise – Facility Layout Evaluation
5.3
Questionnaire
5 Questions
Process Equipment
Learning Outcomes
3
6.1
Module 5
6.2
Practical Exercise — Equipment Qualification Plan (detailed)
6.3
Questionnaire
5 Questions
Documentation and Records
Learning Objectives
3
7.1
Module 6
7.2
Practical Exercise — Batch Record Review (detailed)
7.3
Questionnaire
5 Questions
Materials Management
Learning Objectives
3
8.1
Module 7
8.2
Practical Exercise — Material Receipt Procedure (detailed)
8.3
Questionnaire
5 Questions
Production and In-Process Controls
Learning Objectives
3
9.1
Module 8
9.2
Practical Exercise — IPC (In-Process Control) Strategy Development (detailed)
9.3
Questionnaire
5 Questions
Packaging and Identification
Learning Objectives
3
10.1
Module 9
10.2
Practical Exercise: Label Control System Design
10.3
Questionnaire
5 Questions
Storage and Distribution
Learning Objectives
3
11.1
Module 10
11.2
Detailed Explanation: Practical Exercise: Distribution Control System
11.3
Questionnaire
5 Questions
Laboratory Controls
Learning Objectives
3
12.1
Module 11
12.2
Detailed Explanation: Practical Exercise – Stability Study Protocol
12.3
Questionnaire
5 Questions
Validation
Learning Objectives
3
13.1
Module 12
13.2
Detailed Explanation: Practical Exercise – Cleaning Validation Protocol
13.3
Questionnaire
5 Questions
Change Control
Learning Objectives
3
14.1
Module 13
14.2
Practical Exercise: Change Control Assessment: Manufacturing Process Change
14.3
Questionnaire
5 Questions
Rejection and Re-use
Learning Objectives
3
15.1
Module 14
15.2
Practical Exercise: Material Disposition Decision: Non-Conforming Batch
15.3
Questionnaire
5 Questions
Complaints and Recalls
Learning Objectives
3
16.1
Module 15
16.2
Practical Exercise: Complaint Investigation: Quality Issue Complaint
16.3
Questionnaire
5 Questions
Contract Manufacturers
Learning Objectives
3
17.1
Module 16
17.2
Practical Exercise: Contractor Qualification Program
17.3
Questionnaire
5 Questions
Agents, Brokers, and Distributors
Learning Objectives
3
18.1
Module 17
18.2
Practical Exercise: API Broker Quality System Design
18.3
Questionnaire
5 Questions
APIs by Cell Culture/Fermentation
Learning Objectives
3
19.1
Module 18
19.2
Practical Exercise: Fermentation Process Control Strategy
19.3
Questionnaire
5 Questions
APIs for Clinical Trials
3
20.1
Learning Objectives
20.2
Practical Exercise: Clinical Trial API Strategy – Phase I GMP Implementation
20.3
Questionnaire – Module 19
5 Questions
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