course
The origins of GMP regulations in the GxP Industry
The origins of GMP regulations in the GxP Industry
The origins of GMP regulations in the GxP Industry

About the Course

Introduction to this course: 

This course explores the origins of Good Manufacturing Practices (GMP) regulations in the pharmaceutical industry, delving into historical tragedies that spurred regulatory evolution. Learn from pivotal laws like the Biologics Control Act and the Pure Food and Drug Act, shaping stringent regulatory standards. 


Who should attend: 

This course is ideal for professionals in pharmaceuticals and medical devices seeking a comprehensive understanding of regulatory history and modern compliance. 


Learning Outcomes: 

By the end of this lesson, you will be able to:

  • Recall key historical events and tragedies that prompted the development of GMP.

  • Explain the evolution of regulatory laws and GMP standards from the early 20th century to 1930.

  • Apply knowledge of GMP origins to evaluate current manufacturing practices for compliance


What will I gain: 

Participants will gain a comprehensive understanding of the historical foundations and evolution of GMP in the pharmaceutical and related industries. They will acquire insights into how past tragedies shaped current regulatory standards, empowering them to navigate compliance challenges effectively.


Prerequisites: 

No specific prerequisites are required to attend this course. It is designed to be accessible to professionals across the pharmaceutical, biotechnology, and medical devices industries who wish to deepen their understanding of GMP origins and regulatory evolution.


Additional information: 


Course duration: 00:22:30

Course code/version (effective date): L-101/v1.0 (27/12/2023)


Course Categories

GxP Regulations
Course Progress
Not started
Enroll
Course Outline
  1. The origins of GMP in the GxP Industry
    1. Lesson 1: The origins of GMP (I): from 1900 to 1930
    2. Lesson 2: The origins of GMP (II): from 1937 to 1962
    3. Lesson 3: The 5 pillars of GMP
    4. Reading: The Origins of GMP in America: A Journey of Tragedy, Regulations, and Patient Safety
  2. Additional resources
    1. Mind Map Mind map: The GMP’s Origin This visual resource shows the timeline of GMP's origin. Link to: Mindmap: MINDMAP-1011-1012 v1.0
  3. Survey
    1. Course survey
course
The origins of GMP regulations in the GxP Industry
The origins of GMP regulations in the GxP Industry
Course Progress
Not started
Enroll

About the Course

Introduction to this course: 

This course explores the origins of Good Manufacturing Practices (GMP) regulations in the pharmaceutical industry, delving into historical tragedies that spurred regulatory evolution. Learn from pivotal laws like the Biologics Control Act and the Pure Food and Drug Act, shaping stringent regulatory standards. 


Who should attend: 

This course is ideal for professionals in pharmaceuticals and medical devices seeking a comprehensive understanding of regulatory history and modern compliance. 


Learning Outcomes: 

By the end of this lesson, you will be able to:

  • Recall key historical events and tragedies that prompted the development of GMP.

  • Explain the evolution of regulatory laws and GMP standards from the early 20th century to 1930.

  • Apply knowledge of GMP origins to evaluate current manufacturing practices for compliance


What will I gain: 

Participants will gain a comprehensive understanding of the historical foundations and evolution of GMP in the pharmaceutical and related industries. They will acquire insights into how past tragedies shaped current regulatory standards, empowering them to navigate compliance challenges effectively.


Prerequisites: 

No specific prerequisites are required to attend this course. It is designed to be accessible to professionals across the pharmaceutical, biotechnology, and medical devices industries who wish to deepen their understanding of GMP origins and regulatory evolution.


Additional information: 


Course duration: 00:22:30

Course code/version (effective date): L-101/v1.0 (27/12/2023)


Course Outline
  1. The origins of GMP in the GxP Industry
    1. Lesson 1: The origins of GMP (I): from 1900 to 1930
    2. Lesson 2: The origins of GMP (II): from 1937 to 1962
    3. Lesson 3: The 5 pillars of GMP
    4. Reading: The Origins of GMP in America: A Journey of Tragedy, Regulations, and Patient Safety
  2. Additional resources
    1. Mind Map Mind map: The GMP’s Origin This visual resource shows the timeline of GMP's origin. Link to: Mindmap: MINDMAP-1011-1012 v1.0
  3. Survey
    1. Course survey

Course Categories

GxP Regulations
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