CEU Credits: 0.1
Course Code: ELM-201
Duration: 30 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V3.2
Effective Date: 09/17/2022
Curriculum for this course
Overview
Learning objectives
Who should take this course
Program introduction
Module overview
Overview
What is GMP
What is cGMP
World Health Organization (WHO)
Why GMP?
Overview
Cases from history
1930 - Lubeck BCG Vaccine
1938 - Sulpanilamide
1940 - Contaminated Caps (Lambert, E.C)
1955 - Polio vaccine (Cutter Laboratories)
1962 - Thalidomide
Why GMP is so important?
Overview
GMP regulations and guidelines
How do GMP's different in other countries
WHO
ICH
EMEA
MHRA
US FDA
GMP concepts
What aspects of manufacturing does GMP cover
Final Exam
v3.2 Minor update on 09/25/2025 Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v3.1 Minor update on 07/22/2025 to fix an issue where learners could bypass the exam. The course now requires learner to complete the exam. Course navigation updated to new navigation standards
v3.0 Minor update on 08/29/2022 to update learning objectives to align with the course concepts and content. Updated the final exam with new questions to assess mastery of the updated learning objectives. Updated the final exam to create a question pool from which the course will randomly select at a 3:1 ratio for a total of 10 assessment questions on each final exam attempt.
v2.0 Minor update on 06/27/2022 For the multiple-choice question “GMP is so important because: (Select all that apply)”, the system requires the answer “It allows pharmaceutical manufacturers to increase the price of their drugs” which is an incorrect statement in General but also per the information provided in the video. This answer was changed to incorrect.
v1.0 Course released in 2021