Fundamentals Series

The Fundamentals of Good Manufacturing Practices

Good Manufacturing Practices are followed by life science companies to ensure that the products manufactured meet specific requirements for safety, identity, strength, purity, and quality.

Good Manufacturing Practices are designed to minimize the risks involved in life sciences manufacturing that cannot be eliminated through testing of the final product. In this course, you’ll learn about good manufacturing practices across the entire product lifecycle.

CEU Credits: 0.1
Course Code: ELM-219
Duration: 15 mins
Skill Level: Basic
Language: Chinese (Simplified), English, French (France), German, Italian, Japanese, Polish, Portuguese (Brazil), Russian, Spanish (Spain)
Final Exam: Yes
Certification: Yes
Version: V2.3
Effective Date: 02/12/2024

Curriculum for this course

Course Introduction
What are Good Manufacturing Practices?
The Importance of GMP
Consequences of Non-compliance
Regulatory Framework
Key Elements of GMP
Pre-Manufacturing
At HQ
In the Warehouse
In the Manufacturing Facility
Production and Release
Manufacturing
Manufacturing QA
Commercial Distribution
Quality Systems
QC
Manufacturing, Science and Technology
Validation and Automation
Facilities and Engineering
What We Covered
Test Your Knowledge
Results
v2.3 Minor update on 02/28/2025. Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v2.2 Minor update on 09/06/2024 to add definition of Manufacturing Quality Assurance to glossary
v2.1 Minor update on 04/18/2024 to fix assessment reporting functionality and a grammatical mistake.
v2.0 Major update on 02/12/2024. This course has been redesigned. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well.
v1.3 Minor update on 09/15/2023 to improve user experience
v1.2 Minor update on 12/14/2022 to improve user experience
v1.0 Course released in 2021

Author

Peter Alcocer

Director of eLearning Compliance

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