cGMP – Cases from History and the Regulations

Description:

In this course we will discuss some of the cases from history where the lack of GMP caused devastating effects for patients using medicines. Through the use of real life case studies, it should be very apparent how important it is to take GMP seriously. We will also cover how GMPs differ in other countries and what aspects of manufacturing does GMP not cover.

Curriculum for this course:
Introduction
Overview 50 secs
Learning objectives 45 secs
Who should take this course 1 min 04 secs
Program introduction 1 min 30 secs
Module overview 1 min 06 secs
Module 1: The Starting Line
Overview 1 min 39 secs
What is GMP 1 min 30 secs
What is cGMP 1 min 40 secs
World Health Organization (WHO) 2 min 40 secs
Why GMP? 1 min 39 secs
Module 2: Cases From History
Overview 1 min 50 secs
Cases from history 1 min 31 secs
1930 – Lubeck BCG Vaccine 1 min 56 secs
1938 – Sulpanilamide 56 secs
1940 – Contaminated Caps (Lambert, E.C) 1 min 20 secs
1955 – Polio vaccine (Cutter Laboratories)
1962 – Thalidomide 1 min 25 secs
Why GMP is so important? 1 min 05 secs
Module 3: GMP Regulations and the Guidelines
Overview 1 min 29 secs
GMP regulations and guidelines 1 min 59 secs
How do GMP's different in other countries 2 min 05 secs
WHO 1 min 19 secs
ICH 48 secs
EMEA 1 min 09 secs
MHRA 1 min 49 secs
US FDA 2 min 19 secs
GMP concepts 1 min 39 secs
What aspects of manufacturing does GMP cover 1 min 19 secs
Conclusion
Final Exam
Certification
Author:

Start Learning Today!

We’ve got pricing plans to suit everyone

View Our Pricing Plans