loading

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

22 Sections
41 Lessons
30 Hours

Expand all sectionsCollapse all sections

ICH Q7 – The Story of Global API GMP Harmonization
1
- 1.1
  History
Program Introduction
1
- 2.1
  Introduction to the Active Pharmaceutical Ingredient (API) GMP Training Program
Detailed Glossary
1
- 3.1
  Key GMP and Pharmaceutical Terminology – Foundation for Quality
Module 1: Introduction to ICH Q7
3
- 4.1
  ICH Q7 API GMP – Introduction, Scope & Key Concepts
- 4.2
  Case Study – API Starting Material Determination
- 4.3
  Questionnaire
  20 Minutes5 Questions
Module 2: Quality Management
3
- 5.1
  Quality Management System for API Manufacturing (ICH Q7)
- 5.2
  Practical Exercise – Quality Unit Decision-Making
- 5.3
  Questionnaire – Module 2
  5 Questions
Module 3: Personnel Requirements
3
- 6.1
  Personnel requirements for API Manufacturing (ICH Q7)
- 6.2
  Practical Exercise – Training Program Development
- 6.3
  Module 3: Questionnaire
  5 Questions
Module 4: Buildings and Facilities
3
- 7.1
  Buildings and Facilities requirements for API Manufacturing (ICH Q7)
- 7.2
  Practical Exercise – Facility Layout Evaluation
- 7.3
  Module 4: Questionnaire
  5 Questions
Module 5: Process Equipment
3
- 8.1
  Process Equipment & Systems requirements for API Manufacturing (ICH Q7)
- 8.2
  Practical Exercise — Equipment Qualification Plan
- 8.3
  Module5: Questionnaire
  5 Questions
Module 6: Documentation and Records
3
- 9.1
  Documentation and Records requirements for API Manufacturing (ICH Q7)
- 9.2
  Practical Exercise — Batch Record Review
- 9.3
  Module 6: Questionnaire
  5 Questions
Module 7: Materials Management
3
- 10.1
  Materials Management requirements for API Manufacturing (ICH Q7)
- 10.2
  Practical Exercise — Material Receipt Procedure
- 10.3
  Module 7: Questionnaire
  5 Questions
Module 8: Production and In-Process Controls
3
- 11.1
  Production and In-Process Controls requirements for API Manufacturing (ICH Q7)
- 11.2
  Practical Exercise — IPC (In-Process Control) Strategy Development
- 11.3
  Module 8: Questionnaire
  5 Questions
Module 9: Packaging and Identification
3
- 12.1
  Packaging and Identification Labeling of APIs and Intermediates requirements for API Manufacturing (ICH Q7)
- 12.2
  Practical Exercise: Label Control System Design
- 12.3
  Module 9: Questionnaire
  5 Questions
Module 10: Storage and Distribution
3
- 13.1
  Storage and Distribution Requirements for API Manufacturing (ICH Q7)
- 13.2
  Practical Exercise: Distribution Control System
- 13.3
  Questionnaire
  5 Questions
Module 11: Laboratory Controls
3
- 14.1
  Laboratory Controls
- 14.2
  Detailed Explanation: Practical Exercise – Stability Study Protocol
- 14.3
  Questionnaire
  5 Questions
Module 12: Validation
3
- 15.1
  Validation
- 15.2
  Detailed Explanation: Practical Exercise – Cleaning Validation Protocol
- 15.3
  Questionnaire
  5 Questions
Module 13: Change Control
3
- 16.1
  Change Control
- 16.2
  Practical Exercise: Manufacturing Process Change
- 16.3
  Questionnaire
  5 Questions
Module 14: Rejection and Re-use
3
- 17.1
  Rejection and Re-use
- 17.2
  Practical Exercise: Material Disposition Decision
- 17.3
  Questionnaire
  5 Questions
Module 15: Complaints and Recalls
3
- 18.1
  Complaints and Recalls
- 18.2
  Practical Exercise: Complaint Investigation
- 18.3
  Questionnaire
  5 Questions
Module 16: Contract Manufacturers
3
- 19.1
  Contract Manufacturers
- 19.2
  Practical Exercise: Contractor Qualification Program
- 19.3
  Questionnaire
  5 Questions
Module 17: Agents, Brokers, and Distributors
3
- 20.1
  Agents, Brokers, and Distributors
- 20.2
  Practical Exercise: API Broker Quality System Design
- 20.3
  Questionnaire
  5 Questions
Module 18: APIs by Cell Culture/Fermentation
3
- 21.1
  APIs by Cell Culture/Fermentation
- 21.2
  Practical Exercise: Fermentation Process Control Strategy
- 21.3
  Questionnaire
  5 Questions
Module 19: APIs for Clinical Trials
3
- 22.1
  APIs for Clinical Trials
- 22.2
  Practical Exercise: Clinical Trial API Strategy – Phase I GMP Implementation
- 22.3
  Questionnaire
  5 Questions

Instructor

35 Students

5 Courses

course thumbnail

Free

Student:

6 Students

Lesson:

41 Lessons

Duration: 30 Hours

Quiz:

19 Quizzes

Level: All levels