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Features

Course completion certificate upon passing final assessment

Target audiences

Pharmaceutical manufacturing personnel
Quality Assurance
, Quality Control
Validation
Engineering
Supply Chain staff

Requirements

Basic understanding of pharmaceutical manufacturing

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 Minutes5 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

Instructor

0 Students

2 Courses

course thumbnail

Free

Student:

0 Students

Lesson:

39 Lessons

Duration: 30 Hours

Quiz:

19 Quizzes

Level: All levels