Good Manufacturing Practices (cGMP) - Beginner

The Devastating Effects of Not Following GMP

This course focuses on some of the cases from history where the lack of Good Manufacturing Practices (GMP) caused devastating effects for patients using medicines. The purpose of this course is to illustrate, using real-life case studies, how important it is to take GMP seriously.

CEU Credits: 0.1
Course Code: ELM-710
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.2
Effective Date: 09/27/2023

Curriculum for this course

Course Introduction
What You'll Learn
What is GMP?
Worldwide GMP Regulations
Harm to Patients
EzriCare Artificial Tears
Lessons Learned
Lack of Drug Supply
L-Cysteine Hydrochloride Injections
Lessons Learned
Financial and Reputation Damage
Akorn Pharma
Lessons Learned
Conclusion
What We Covered

Test You Knowledge

Results

v2.2 - Course updated on 10/01/2024 to fix pronunciation of sulfanilamide in course introduction. One quiz question updated for clarity
v2.1 - Course updated on 02/08/2024 to resolve incorrect feedback in three exam questions
v2.0 - This course has been redesigned and released on 11/08/2023. The course content, objectives, and visual design have been updated to comply with the latest GMP standards. Additionally, the course now includes recent real-life examples of the impact of non-compliance.
v1.1 - Course updated on 08/29/2023 to improve quiz functionality
v1.0 - Course released on 08/24/2021

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering

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